| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 027 06 23 000 | SIEMENS | Luminos Agile Max.
Luminos dRF Max | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199944
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199947 |
| mdprc 021 05 23 000 | DermLite LLC | DERMLITE DL4W | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199376 |
| mdprc 039 12 22 000 | Hill Rom Inc | Hill-Rom Progressa Bed System | FDA |
| mdprc 021 09 22 001 | Philips Healthcare | DigitalDiagnost C50 1.1 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195576 |
| mdprc 019 09 22 000 | ICU Medical, Inc. | MicroClave | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195578
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195579
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195572
http://www.accessda |
| mdprc 017 09 22 000 | ICU Medical, Inc | ChemoLock Closed System Drug Transfer Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195731
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195036 |
| mdprc 021 06 22 001 | Instrumentation Laboratory SpA, a Werfen Company | ACL TOP 300 CTS, ACL TOP 350 CTS, ACL TOP 500 CTS, ACL TOP 550 CTS, and ACL TOP 970 CL | FDA, NCMDR |
| mdprc 011 07 22 000 | Diagnos Inc. | CARA (Computer Assisted Retinal Analysis) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192285 |
| mdprc 019 05 22 000 | SIEMENS | SOMATOM with software syngo CT VA30A_SP4 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192851 |
| mdprc 039 03 22 000 | Bio-Rad Laboratories Inc | BioPlex 2200 SYPH T PACK Syphilis Total & RPR Reagent Pack & BioPlex 2200 Syphilis Total & RPR Calibrator Set CAL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192210 |
| mdprc 021 03 22 000 | Smiths Medical International Limited. | Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190636 |
| mdprc 006 03 22 000 | Hill Rom Inc | NaviCare and Voalte Nurse Call Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189999 |
| mdprc 026 12 21 000 | Wright Medical Technology, Inc. | Stryker CLAW II ORTHOLOC and Stryker DARCO Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190461 |
| mdprc 019 11 21 000 | Hitachi Ltd. | Arietta 850 Ultrasound; Lisendo 880 Ultrasound | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189705 |
| mdprc 015 11 21 000 | Dentech Corp. | Rubber Dam Clamp, KSK | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187238 |
| mdprc 022 09 21 000 | Siemens Healthcare Diagnostics, Inc | Atellica IM BR 27.29 (BR) Assay 250 Test Kit | US. FDA |
| mdprc 009 09 21 000 | Hitachi Medical Corp | ECHELON MRI System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188704 |
| mdprc 033 08 21 000 | Pentax of America Inc | Pentax Medical Video Duodenoscope | FDA |
| mdprc 007 08 21 000 | Sunrise Medical | Zippie Voyage | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188302 |
| mdprc 001 08 21 000 | Siemens Healthcare Diagnostics | ADVIA Chemistry XPT System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187838 |
| mdprc 003 07 21 000 | Quidel Corporation | Lyra SARSCoV2 Assay (M120) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187617 |
| mdprc 033 06 21 000 | Fujifilm Medical Systems U.S.A., Inc. | Synapse PACS - Radiological Image Processing System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=186333 |
| mdprc 021 06 21 000 | Terumo Cardiovascular Systems Corporation | Sarns TCM II and TCM & Terumo HX2 Temperature Management System | U.S. FDA |
| mdprc 019 10 20 001 | ESAOTE S.P.A | AC/DC POWER SUPPLY for 7400 | NCMDR |
| mdprc 036 10 20 000 | Quidel Corporation | Sofia SARS Antigen FIA Package Insert | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183267 |
| mdprc 034 10 20 000 | Gentian AS. | Gentian Cystatin C Immunoassay | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183752 |
| mdprc 026 10 20 000 | Beckman Coulter | UIBC System reagent | U.S. FDA |
| mdprc 002 06 19 003 | Teleflex Medical | RUSCH LASERTUBE (Rubber) | NCMDR |
| mdprc 095 01 18 001 | SybronEndo Corporation | Elements Obturation Unit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160754 |
| mdprc 028 09 20 000 | Siemens Medical Solutions | Symbia S-Series and Symbia T-Series | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183240 |
| mdprc 025 06 20 000 | Philips Healthcare | Philips Sterilizable Defibrillator Internal Paddles | http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00367-1 |
| mdprc 011 06 20 000 | The Magstim Company Limited | Rapid2 and Horizon PSU Stim Interconnecting Cable | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=180785 |
| mdprc 006 05 20 000 | Carl Zeiss - Micro Imaging Microscopes | Component for Laser Scanning Microscopes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=177441 |
| mdprc 027 04 20 000 | MAQUET Cardiopulmonary GmbH | Avalon Elite Vascular Access Kit | US. FDA |
| mdprc 006 04 20 001 | DexCom Inc | Dexcom G4 PLATINUM Continuous Glucose Monitoring System
Dexcom G5 Continuous Glucose Monitoring System
Dexcom G6 Continuous Glucose Monitoring System
| NCMDR |
| mdprc 009 03 20 000 | BREAS Medical AB A GE Healthcare Co | Protective Cover (Part No. 006344) for Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=179485 |
| mdprc 010 02 20 000 | Palodex Group Oy | DIGORA Optime, GXPS500, KaVo Scan eXam and Instrumentarium Dental Express (FLAT PANEL/DIGITAL IMAGER) | US. FDA |
| mdprc 040 12 19 000 | Zimmer, INC… | Compress, Mini Compress | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176438 |
| mdprc 040 11 19 000 | Heritage Medical Products. | 2000 vascular with 30 degree option | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174205 |
| mdprc 029 11 19 000 | XODUS MEDICAL Inc. | Cautery Tip Cleaner | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176421 |
| mdprc 022 11 19 000 | Life Technologies Limited. | StemPro MSC SFM CTS, CTSTM Essential 8 Medium | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174658 |
| mdprc 008 10 19 000 | Roche Diagnostics Corp | AccuChek Connect App | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175749 |
| mdprc 006 10 19 000 | Medline Industries, Inc. | Electrical surgical clipper and base | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176259 |
| mdprc 162 09 19 000 | Elekta Business Area Software Systems IMPAC Medical Systems Inc. | Monaco RTP System. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176158 |
| mdprc 140 09 19 000 | Maquet Cardiovascular,LLC. | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176040 |
| mdprc 139 09 19 000 | Vital Scientific N.V. | V-Twin | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175935 |
| mdprc 138 09 19 000 | Arrow International Inc | Arrow QuadLumen Central Venous Catheterization Kit, ARROWgard Blue PSI Kit CathGard | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175814 |
| mdprc 124 09 19 000 | SENTINEL CH. SpA | Multigent Lithium Assay, Alinity c Lithium Reagent Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175596 |
| mdprc 123 09 19 000 | Philips Healthcare | IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176103 |
| mdprc 122 09 19 000 | Philips Healthcare | DigitalDiagnost C50 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176038 |
| mdprc 121 09 19 000 | Musculoskeletal Transplant Foundation, Inc.. | QuickGraft | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176019 |
| mdprc 098 09 19 000 | MAQUET Cardiopulmonary GmbH | HLS Set Advanced 7.0 Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174814 |
| mdprc 097 09 19 000 | Ad-Tech Medical Instrument Corp | ADTECH Drill Sleeve Guides | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175964 |
| mdprc 094 09 19 000 | Dynex Technologies Ltd | Dynex DSX Instrument | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175187 |
| mdprc 093 09 19 000 | Exactech | Threaded Offset Cup Impactor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175607 |
| mdprc 092 09 19 000 | Teleflex Medical.. | Hudson RCI Sheridan LTS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175293 |
| mdprc 080 09 19 000 | Philips Healthcare | HeartStart MRx | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175784 |
| mdprc 079 09 19 000 | LeMaitre Vascular GmbH | Lemaitre Aortic Occlusion Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175640 |
| mdprc 078 09 19 000 | Integra LifeSciences | Integra Jarit Gemini Clamp 9 inch | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175161 |
| mdprc 077 09 19 000 | Helena Biosciences | Titan Gel Serum Protein Control (SPE Control) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168437 |
| mdprc 076 09 19 000 | Getinge Disinfection AB | Getinge MCC Flow i Disposable CO2 absorber | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175330 |
| mdprc 075 09 19 000 | FUJIFILM Medical Systems | Fujifilm FDR Go Plus mobile Xray system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175614 |
| mdprc 074 09 19 000 | Coltene Whaledent Inc. | DIATECH, ROUND END TAPER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175056 |
| mdprc 073 09 19 000 | Becton Dickinson & Co. (BD) | BD Kiestra InoqulA Software Version 20.3. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175594 |
| mdprc 072 09 19 000 | AngioDynamics Inc | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174798 |
| mdprc 071 09 19 000 | Karl Storz Endoscopy UK Ltd | Intubation Fiberscope | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175600 |
| mdprc 041 09 19 000 | Medline Industries Inc. | Medline Sterile Piston Irrigation Syringe Tray with Saline | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175718 |
| mdprc 040 09 19 000 | Agilent Technologies.. | K6460 Triple Quadrupole MS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173417 |
| mdprc 039 09 19 000 | Leventon S. A. U. | DOSIFUSER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173331 |
| mdprc 038 09 19 000 | Becton Dickinson & Co. (BD) | CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175641 |
| mdprc 037 09 19 000 | Ad-Tech Medical Instrument Corp | Depth Electrodes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172558 |
| mdprc 017 09 19 000 | Medline Industries, Inc. | Primary Warmer Packs Containing Vyaire enFlow Disposable Cartridges . | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173166 |
| mdprc 014 09 19 000 | Radiometer America Inc | ABL90 FLEX | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174676 |
| mdprc 013 09 19 000 | Luminex Molecular Diagnostics Inc | ARIES System, ARIES M1 System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168673 |
| mdprc 050 08 19 000 | Integra LifeSciences | Codman ISOCOOL Bipolar Forceps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175411 |
| mdprc 043 08 19 000 | Centurion Medical Products | Various Products: Speculum, vaginal, metal, Dressing tray, Circumcision tray | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174737 |
| mdprc 042 08 19 000 | Ortho-Clinical Diagnostics | VITROS 250, 250AT, 350, 4600, 5600 and 5,1 FS chemistry systems. clinical chemistry analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174829 |
| mdprc 041 08 19 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products GLU Slides | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174082 |
| mdprc 040 08 19 000 | Ad-Tech Medical Instrument Corp | LSB Style Anchor Bolt | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174373 |
| mdprc 039 08 19 000 | Hycor Biomedical Inc. | HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174649 |
| mdprc 038 08 19 000 | DRG Instruments GmbH | DRG Salivary Testosterone ELISA | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173940 |
| mdprc 037 08 19 000 | Polymer Technology Systems, Inc. | PTS Panels Lipid Panel test strip. Ref Number: 1710. Henry Schein Panels Lipid Panel test strip. Ref Number: 570-0414 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173514 |
| mdprc 036 08 19 000 | Fresenius Medical Care. | Liberty Cycler Cassettes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173897 |
| mdprc 035 08 19 000 | Howmedica Osteonics Corp. | Serrato 9.5mm X 90mm Polyaxial Screw, Serrato 9.5mm X 100mm Polyaxial Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174853 |
| mdprc 005 08 19 000 | Terumo Medical Corp.. | Capiox NX19 Oxygenator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174208 |
| mdprc 004 08 19 000 | Inovo, Inc | Single Luman Conserver | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172722 |
| mdprc 003 08 19 000 | Hycor Biomedical Inc. | Autostat II Rheumatoid Factor IgM ELISA | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173183 |
| mdprc 002 08 19 000 | Centurion Medical Products | Sheridan Endotracheal Tube | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174007 |
| mdprc 001 08 19 000 | Alto Development Corp | A&E Medical Corp. UltraFlex | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174555 |
| mdprc 114 07 19 000 | GETINGE US SALES LLC | PulsioFlex Monitor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174106 |
| mdprc 113 07 19 000 | Epimed International, Inc. | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174227 |
| mdprc 112 07 19 000 | Encore Medical, Lp | DJO Surgical | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173392 |
| mdprc 111 07 19 000 | CellEra LLC | VITALE Silicon Foam Dressings 4"x4" | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174543 |
| mdprc 110 07 19 000 | Laborie Medical Technologies | Power Supply Units Used with Solar Blue Urodynamic Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174669 |
| mdprc 109 07 19 000 | Wilson-Cook Medical, Inc. | Acuject Variable Injection Needle | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173789 |
| mdprc 108 07 19 000 | Bard Pcripheral Vascular (BPV) | Powerport Cleavue Slim Implantable Port | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171729 |
| mdprc 107 07 19 000 | Teleflex Medical. | Rusch EasyCath Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174360 |
| mdprc 106 07 19 000 | Ralston Group | Maximum Pelvic Trainer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174733 |
| mdprc 095 07 19 000 | Zyno Medical LLC | Administration Sets | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173367 |
| mdprc 094 07 19 000 | Merge Healthcare Corp. | Merge PACS and Merge OrthoPACS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174647 |
| mdprc 093 07 19 000 | InfuTronix LLC | Nimbus Administration Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173300 |
| mdprc 078 07 19 000 | Stanley Healthcare Solutions | STANLEY Healthcare Arial 54315 Network Manager environmental control, powered | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174497 |
| mdprc 065 07 19 000 | DeRoyal Industries Inc. | CRANI PACK | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173848 |
| mdprc 063 07 19 000 | Teleflex Medical.. | HUDSON RDI NEONATAL ConchaSmart Breathing Circuit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173297 |
| mdprc 062 07 19 000 | Cooper Surgical, Inc. | Advincula Delineator Uterine Manipulators with Soft Koh-Efficient , | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173714 |
| mdprc 059 07 19 000 | Pharmaceutical Innovations, Inc. | ElectroMist | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174062 |
| mdprc 058 07 19 000 | GE Healthcare | Ultrasound Probe RIC59D and Repair RIC59ARS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174509 |
| mdprc 057 07 19 000 | Rinovum Women's Health | Revive Reusable Bladder Support | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173348 |
| mdprc 056 07 19 000 | Boston Scientific | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156048 |
| mdprc 028 07 19 000 | Metrex Research, LLC | Regimen 28 Day Glutaraldehyde Sterilizing and Disinfecting Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171828 |
| mdprc 027 07 19 000 | Helena Biosciences Europe | ColoCARE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173480 |
| mdprc 017 07 19 000 | Philips Healthcare | Vereos PET/CT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173945 |
| mdprc 016 07 19 000 | Infinium Medical, Inc. | CLEO Patient Monitor /Tranquility VS Patient Monitor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173303 |
| mdprc 015 07 19 000 | Cardiac Science Corporation | Powerheart G5 Automatic AED | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173699 |
| mdprc 014 07 19 000 | Baxter | REVACLEAR 400, REVACLEAR 300 Dialyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173325 |
| mdprc 002 07 19 000 | johnson & johnson Surgical Vision Inc. | Disposable 25GA Vitrectomy Cutter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172948 |
| mdprc 001 07 19 000 | Hitachi | PROBEAT-V | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173428 |
| mdprc 099 06 19 000 | Medtronic | Hancock II T510 Bioprosthesis, Mosaic 310 Bioprosthesis, | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173390 |
| mdprc 081 06 19 000 | Tecan | Freedom EVO 200 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172787 |
| mdprc 080 06 19 000 | Thermo Fisher | Fisher Scientific Isotemp -General Purpose Water Bath | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173202 |
| mdprc 075 06 19 000 | Zimmer, INC…. | The MobiC Cervical Disc Prosthesis (MobiC; MobiC 14mm Distraction Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173314 |
| mdprc 074 06 19 000 | Ethicon Inc. | Ethicon ETHIBOND EXCEL Polyester Sutures | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173104 |
| mdprc 073 06 19 000 | CooperSurgical Inc.. | LEEP Precision Integrated System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172775 |
| mdprc 072 06 19 000 | Skytron LLC | Steam Sterilizer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172192 |
| mdprc 071 06 19 000 | Monarch Medical Technologies | Monarch Medical Technologies EndoTool IV | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172822 |
| mdprc 055 06 19 000 | ConforMIS | iTotal Hip Replacement System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172560 |
| mdprc 035 06 19 000 | Zimmer Biomet, Inc. | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172762 |
| mdprc 034 06 19 000 | Terumo Medical Corp. | Advanced Perfusion System 1 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172970 |
| mdprc 030 06 19 000 | Zimmer Biomet, Inc. | Lineum 4.35mm x 28mm Translation Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172921 |
| mdprc 029 06 19 000 | OMNIlife science | OMNIBotics iBlock Cutting Guide | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172729 |
| mdprc 028 06 19 000 | Centurion Medical Products | Sterile Nail Nipper | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172293 |
| mdprc 021 06 19 000 | Smiths Medical | JELCO Hypodermic Needle-Pro EDGE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171714 |
| mdprc 020 06 19 000 | NxStage Medical, Inc. | NxStage PureFlow B Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172387 |
| mdprc 001 06 19 000 | Exatech inc. | Opteform Allograft | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172638 |
| mdprc 116 05 19 000 | Polymer Technology Systems, Inc… | PTS Panels | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171371 |
| mdprc 115 05 19 000 | Oakworks | Oakworks Imaging Tables | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172888 |
| mdprc 083 10 17 001 | CareFusion Alaris A BD Co | Alaris Pump Module model 8100 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158454 |
| mdprc 097 05 19 000 | Remel Inc. | Thio Med w/o Ind, w/Dex | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172384 |
| mdprc 096 05 19 000 | Neusoft Medical Systems | NeuViz 64 Multi-slice, 128 Multislice and 16 Essence Multislice CT Scanner System. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172628 |
| mdprc 095 05 19 000 | Collagen Matrix, Inc. . | Neomem | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172146 |
| mdprc 094 05 19 000 | KaVo Dental GmbH | DEXIS Titanium Intraoral Sensor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172388 |
| mdprc 093 05 19 000 | Remel Inc. | Thio Med w/Dex, Hem, Vit, K (7ml) and (5ml) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172342 |
| mdprc 087 05 19 000 | Cooper Surgical, Inc. | ICSI MICROPIPETTE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172286 |
| mdprc 086 05 19 000 | Roche Diagnostics Corp | Cobas infinity central lab IT solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171034 |
| mdprc 085 05 19 000 | Compass Health Brands | MediPress Segmental Garments | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172123 |
| mdprc 084 05 19 000 | Integra LifeSciences | Integra Flowable Wound Matrix | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172221 |
| mdprc 083 05 19 000 | Stanley Healthcare Solutions | M200 Fall Monitoring System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168681 |
| mdprc 082 05 19 000 | Terumo Medical Corp.. | Advanced Perfusion System 1_ | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172129 |
| mdprc 068 05 19 000 | PENTAX Europe GmbH | Pentax Medical C2 CryoBalloon | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171259 |
| mdprc 067 05 19 000 | OpGen Inc. | GNR PNA FISH Control Slide kit CS01110 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172289 |
| mdprc 040 05 19 000 | Medica Corporation. | Medica Wash1-Wash solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171152 |
| mdprc 023 05 19 000 | Philips Healthcare | Fetal Spiral Electrodes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171593 |
| mdprc 022 05 19 000 | Molnlycke Health Care AB. | EZ Derm Porcine Xenografts | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171757 |
| mdprc 145 04 19 000 | Philips Healthcare | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172033 |
| mdprc 144 04 19 000 | Matrix Surgical Pty Ltd | OmniPore Surgical Implants | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171695 |
| mdprc 143 04 19 000 | Ossur | MR-Conditional Halo System Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170606 |
| mdprc 132 04 19 000 | KaVo Dental | ORTHOPANTOMOGRAPH OP 3D CBCT xray systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170734 |
| mdprc 131 04 19 000 | Fresenius Kabi Ltd | CATSmart device (Continuous autotransfusion System) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171537 |
| mdprc 130 04 19 000 | Exatech | Truliant Tibial Fit Tray Cemented SZ 3F / 3T | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171680 |
| mdprc 108 04 19 000 | ProSun International, LLC | Tanning bed | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171404 |
| mdprc 105 04 19 000 | Integra LifeSciences | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome Total Ankle Prosthesis | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171498 |
| mdprc 095 04 19 000 | Encore Medical, Lp | Exprt Precision System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171507 |
| mdprc 094 04 19 000 | Ulrich GmbH & Co. KG | ULRICH Torque Limiting HandleTorque Wrench | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171706 |
| mdprc 093 04 19 000 | Roche Diagnostics Corp | Bilirubin Total Gen.3, Tina-quant IgM Gen.2 and Lactate Gen.2 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170149 |
| mdprc 092 04 19 000 | Pintler Medical LLC | Heated OR Torso pad of the Pintler Patient Warming System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171774 |
| mdprc 035 04 16 001 | Philips Healthcare | Foot Switches used with the Multiple systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171650 |
| mdprc 091 04 19 000 | Philips Burton | Azurion FlexArm | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171662 |
| mdprc 090 04 19 000 | Johnson & Johnson Vision Care | ACUVUE OASYS for ASTIGMATISM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171551 |
| mdprc 089 04 19 000 | Depuy Orthopaedics, Inc | CORAIL AMT STANDARD OFFSET NECK SEGMENT, CORAIL AMT HIGH OFFSET NECK SEGMENT and CORAIL AMT COXA VARA NECK SEGMENT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171429 |
| mdprc 088 04 19 000 | Becton Dickinson & Co. (BD) | BD Gravity IV Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171415 |
| mdprc 087 04 19 000 | Beaver Visitec International Ltd | Beaver Xstar Slit Knife 2.4 mm, 45 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171509 |
| mdprc 064 04 19 000 | ConforMIS | iTotal CR Total Knee Replacement System, | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170906 |
| mdprc 060 04 19 000 | Zimmer, INC…. | Biomet RingLoc Hip System SelfTapping Bone Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171366 |
| mdprc 059 04 19 000 | LivaNova PLC | SORIN Heater-Cooler System 3T | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171458 |
| mdprc 058 04 19 000 | Integra Limited | Integra bioBLOCK Resorbable subtaler Implant | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171442 |
| mdprc 011 04 19 000 | Philips Healthcare | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171236 |
| mdprc 009 04 19 000 | Medical Action Industries Inc | Laparotomy Sponges | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171319 |
| mdprc 006 04 19 000 | MAQUET Cardiovascular LLC | Cardiohelp Emergency Drive | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171237 |
| mdprc 003 04 19 000 | ICU Medical, Inc | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169676 |
| mdprc 002 04 19 000 | CryoLife, Inc. | OnX Aortic Heart Valve | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170731 |
| mdprc 001 04 19 000 | ConforMIS | iTotal Posterior Stabilized (PS) Knee Replacement System. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170909 |
| mdprc 096 03 19 000 | Keystone Dental Inc. | PalTop | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171470 |
| mdprc 095 03 19 000 | Beaver Visitec International Ltd | BVI Visitec Soft Tip Cannula | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169745 |
| mdprc 094 03 19 000 | Accelerate Diagnostics Inc | Accelerate Pheno system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171153 |
| mdprc 090 03 19 000 | Randox Laboratories Ltd. | Randox Blood Gas Control Level 2 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171118 |
| mdprc 089 03 19 000 | Fenwal | CATSmart Vacuum Pump | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171116 |
| mdprc 085 03 19 000 | Smith & Nephew inc | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169782 |
| mdprc 084 03 19 000 | LW Scientific, Inc. | LW Scientific ZIP IQ PCV Centrifuge | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171148 |
| mdprc 083 03 19 000 | ConvaTec | Nelaton Urinary Catheter, Feeding Tube Metric, FilterFlow Suction Handle CH24, Forceps Blue | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170714 |
| mdprc 082 03 19 000 | Becton Dickinson & Co. (BD) | BD Synapsys Microbiology Informatics Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171162 |
| mdprc 081 03 19 000 | Avitus Orthopaedics, Inc. | Avitus | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171254 |
| mdprc 080 03 19 000 | ACell Inc | Gentrix Thick Surgical Matrices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171171 |
| mdprc 070 03 19 000 | CP Medical Inc | Plain and Chromic Gut Absorbable Surgical Sutures | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171120 |
| mdprc 025 03 19 000 | Reckitt Benckiser Healthcare | Durex Pleasure Pack. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170511 |
| mdprc 024 03 19 000 | Microbiologics | Cepheid Respiratory Control Panel | Q.M.S. Co. Ltd https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170853 |
| mdprc 023 03 19 000 | Linet spol. s r.o. | AVE 2 Birthing Beds | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170332 |
| mdprc 014 03 19 000 | Stryker Sustainability Solutions | Stryker Sustainability Solutions (SSS) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170821 |
| mdprc 003 03 19 001 | Becton Dickinson & Co. (BD) | Phoenix ASTs Indicator | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00332-1 |
| mdprc 002 03 19 000 | Zimmer, INC…. | Biomet Comprehensive Reverse Shoulder | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167479 |
| mdprc 001 03 19 000 | PENTAX | C2 CryoBalloon Ablation System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169563 |
| mdprc 135 02 19 000 | Terumo Medical Corp.. | Terumo Cardiovascular Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170572 |
| mdprc 134 02 19 000 | Shimadzu Medical Systems. | BRANSIST safire | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170523 |
| mdprc 133 02 19 000 | BrosMed Medical Co.,Ltd. | Hermes NC PTA Balloon Dilation Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170512 |
| mdprc 132 02 19 000 | bioMerieux Inc | Vitek 2 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170347 |
| mdprc 131 02 19 000 | American Contract Systems, Inc. | Surgical convenience kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169600 |
| mdprc 130 02 19 000 | Abbott Vascular | Plus 30 PRIORITY PACK (Accessories Kits) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170566 |
| mdprc 129 02 19 000 | Exactech | Equinoxe Preserve Humeral Stem, 8mm | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170578 |
| mdprc 090 02 19 000 | Zimmer, INC…. | Vanguard Knee System Series-A Standard Patella | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170553 |
| mdprc 089 02 19 000 | ICU Medical, Inc | ChemoLock Vial Spikes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170359 |
| mdprc 085 02 19 000 | Baxter | Kaguya Automated Peritoneal Dialysis System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169659 |
| mdprc 073 02 19 000 | Teleflex Medical , | Pilling COOLEY SUMPSUCTION TUBE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170297 |
| mdprc 072 02 19 000 | Smiths Medical International Limited | Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin and Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166689 |
| mdprc 071 02 19 000 | Signature Orthopaedics | Genius Total Knee System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170488 |
| mdprc 070 02 19 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Myoglobin Calibrators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169785 |
| mdprc 069 02 19 000 | bioMerieux Inc | VITEK 2 ASTN351 Test Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170402 |
| mdprc 068 02 19 000 | AtriCure | COBRA FUSION 50 and 150 Ablation System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170344 |
| mdprc 062 02 19 000 | STERIS Corporation. | ATLAS Loading Car | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170576 |
| mdprc 050 02 19 000 | West Pharma Services IL | Vial2Bag Direct Connect 13 mm IV Fluid Transfer Sets | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170468 |
| mdprc 045 02 19 000 | Argon Medical Devices Inc | Bone marrow needle | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170494 |
| mdprc 044 02 19 000 | Neusoft Medical Systems | NeuViz 128 Multislice CT Scanner System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170298 |
| mdprc 023 11 18 001 | Roche Diagnostics Corp | CoaguChek XS Test Strips INST 48CT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170144 |
| mdprc 042 01 19 001 | Arrow International Inc | Arrow CVC | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169383 |
| mdprc 016 02 19 000 | XTANT MEDICAL INC | Calix Lumbar Spinal Implant System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170253 |
| mdprc 005 02 19 000 | Roche Diagnostics Corp | Elecsys Anti HAV IgM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170000 |
| mdprc 084 01 19 001 | Cook Medical Europe Limited, | Captura Serrated Large Forcep | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170186 |
| mdprc 083 01 19 000 | LivaNova PLC | Perfusion Tubing Systems Containing Stopcocks and Stopcock Manifolds. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169426 |
| mdprc 078 01 19 002 | Stryker Sustainability Solutions | BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170204 |
| mdprc 077 01 19 001 | LivaNova PLC | Perfusion Tubing Systems Containing Stopcocks and Stopcock Manifolds. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169426 |
| mdprc 067 01 19 000 | Kimberly Clark Health Care.. | U by Kotex Sleek Tampons | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169746 |
| mdprc 066 01 19 000 | Fetzer Medical GmbH & Co. KG | Obstetric Forceps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170175 |
| mdprc 059 01 19 000 | DeRoyal Industries Inc. | DeRoyal(R) Enteral Safe Feed Tube, REF 542465 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169992 |
| mdprc 058 01 19 000 | Meridian Bioscience Inc | PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169846 |
| mdprc 045 01 19 000 | Zimmer, INC…. | Biomet DVR Crosslock Screws | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169576 |
| mdprc 044 01 19 000 | Smith & Nephew inc | SL PLUS MIA DOUBLE OFFSET ADAPTER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170307 |
| mdprc 043 01 19 000 | Canadian Hospital Specialties | MEDRX POLYURETHANE FEEDING TUBE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169778 |
| mdprc 041 01 19 000 | Cardinal-Health | Presource Kit Total Joint Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169742 |
| mdprc 037 01 19 000 | Swissray | Swissray ddRCombi Trauma | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169713 |
| mdprc 012 01 19 000 | Ultradent products INC. | Enamelast Cool Mint/OT Varnish 5 NaF Mint | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168643 |
| mdprc 001 01 19 000 | Medtronic SA | StealthStation Cranial and Synergy Cranial Depth Gauge | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167816 |
| mdprc 126 12 18 000 | Randox Laboratories Ltd. | Liquid Protein Calibrators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169364 |
| mdprc 125 12 18 000 | Tosoh Corporation | Tosoh AIA Packs | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169033 |
| mdprc 124 12 18 000 | KONICA MINOLTA, INC | KDR UArm, Bucky and Tubestand | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169254 |
| mdprc 123 12 18 000 | In2Bones, SAS | NeoSpan SuperElastic Compression Staple with Instruments | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169279 |
| mdprc 122 12 18 000 | Howmedica Osteonics Corp. | HydroSet XT Injectable HA Bone Cement | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169172 |
| mdprc 121 12 18 000 | Fresenius Medical Care. | Optiflux F160NR Dialyzers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169039 |
| mdprc 120 12 18 000 | Bracco Injeneering S.A. | Empower FastLoad CT Syringe Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169073 |
| mdprc 113 12 18 000 | Theragenics Corporation | Theragenics Brachytherapy needles | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168923 |
| mdprc 112 12 18 000 | bioMerieux Inc | VITEK 2 & VITEK 2 Compact | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169023 |
| mdprc 111 12 18 000 | Advanced Instruments Inc | GloCyte Automated Cell Counter System, GloCyte Low and High Level Controls | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162695 |
| mdprc 108 12 18 000 | Covidien LLC…. | Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169031 |
| mdprc 107 12 18 000 | Bausch & Lomb GmbH.. | enVista One Piece Hydrophobic Acrylic Intraocular lens | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169043 |
| mdprc 081 12 18 000 | Tosoh Corporation | AIA2000 and AIA900 Analyzers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167743 |
| mdprc 080 12 18 000 | Tosoh Corporation | AIA900 Automated Immunoassay Analyzer. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167650 |
| mdprc 079 12 18 000 | Tosoh Corporation | AIA360 Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167620 |
| mdprc 078 12 18 000 | Philips Healthcare | Xper Flex Cardio Patient Monitoring Systems (FC2010, FC2020) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168911 |
| mdprc 077 12 18 000 | Abbott Laboratories Inc | i-STAT CG8+ Cartridges | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167569 |
| mdprc 069 12 18 000 | AngioDynamics Inc | Navilyst Medical BioFlo PICC with ENDEXO and PASV | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168815 |
| mdprc 058 12 18 000 | Philips Healthcare | IntelliVue MX40 Patient Monitor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168916 |
| mdprc 054 12 18 000 | Zimmer, INC…. | Comprehensive Mini Stem, Orthopedic Salvage System (OSS) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168913 |
| mdprc 053 12 18 000 | Tosoh Corporation | AIA360 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167366 |
| mdprc 052 12 18 000 | Leoni Fiber Optics GmbH | Laser Fiber Assy-Single Use | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168872 |
| mdprc 051 12 18 000 | Arjo Inc | Flite Clip Sling, 4 Point | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168967 |
| mdprc 030 12 18 000 | Pfizer Limited | Various Thermacare Heat Wraps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167683 |
| mdprc 029 12 18 000 | Zimmer, INC | Biomet 20mm Compress Device Short Anchor Plug With Drill Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168863 |
| mdprc 025 12 18 000 | Invacare Corporatio | Invacare 9805 and 9805P Hydraulic Patient Lifts | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167386 |
| mdprc 013 12 18 000 | Becton Dickinson & Co. (BD) | BD BBL Trypticase Soy Agar with 5 Sheep Blood, Catalog No. 221261 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168983 |
| mdprc 012 12 18 000 | ASO, LLC | First Aid Sterile Gauze Pad | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168957 |
| mdprc 008 12 18 000 | Tosoh Corporation | AIA900 Automated Immunoassay Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167811 |
| mdprc 007 12 18 000 | PerkinElmer Life and Analytical Sciences | QSight 210 MD Mass Spectrometer Simplicity 3Q MD | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167969 |
| mdprc 006 12 18 000 | NuMED, Inc. | MultiTrack Angiographic Catheter (MMTA) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168770 |
| mdprc 005 12 18 000 | Eurotrol B.V | Eurotrol HemoTrol Hemoglobin Controls.. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168810 |
| mdprc 004 12 18 000 | W.O.M. World of Medicine GmbH . | PNEUMOCLEAR | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168818 |
| mdprc 098 11 18 000 | Zimmer, INC…. | Vanguard Knee System PS Open Box Femoral Right and left | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168792 |
| mdprc 097 11 18 000 | Becton Dickinson & Co. (BD) | BD Vacutainer Urine Cups | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167544 |
| mdprc 081 11 18 000 | GE Healthcare | DeltaVision OMX SR Imaging System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168762 |
| mdprc 080 11 18 000 | SVS LLC | PremierPro Aluminum Adjustable Walker | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168385 |
| mdprc 079 11 18 000 | Tosoh Corporation | Tosoh AIA-900 immunoassay Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167822 |
| mdprc 069 11 18 000 | Zimmer, INC…. | The Affixus Hip Fracture Nail System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167854 |
| mdprc 068 11 18 000 | Voluntis | Insulia Diabetes Management Companion | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168856 |
| mdprc 067 11 18 000 | Tosoh Corporation | Recall AIA900 Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167729 |
| mdprc 066 11 18 000 | Tosoh Corporation | AIA2000 Analyzer | FDA |
| mdprc 065 11 18 000 | Stryker | Reprocessed LASSO NAV eco Electrophysiology Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168248 |
| mdprc 064 11 18 000 | Straumann Manufacturing, Inc. | Endosseous dental implant abutment | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168765 |
| mdprc 063 11 18 000 | Invivo Corporation | Xper Flex Cardio Physiomonitoring System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167437 |
| mdprc 062 11 18 000 | Canon Inc | RadPRO Mobile 40kW Digital X-Ray Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168732 |
| mdprc 061 11 18 000 | American Contract Systems, Inc. | Powdered Surgical Glvoes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166267 |
| mdprc 102 04 18 001 | Zimmer Biomet, Inc. | Intramedullary Fixation | BfArM |
| mdprc 051 11 18 000 | Safe N Simple, LLC | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167530 |
| mdprc 050 11 18 000 | Medtronic SA | Medtronic Navigation | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168363 |
| mdprc 049 11 18 000 | Integrity Implants Inc. | FlareHawk | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167968 |
| mdprc 048 11 18 000 | Fannin UK Ltd | Espiner Tissue Retrieval System.. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167206 |
| mdprc 047 11 18 000 | BioFire Diagnostics Inc | BioFire FilmArray Meningitis/Encephalitis (ME) Panel | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167757 |
| mdprc 046 11 18 000 | Arthrex Inc | 3.2mm Proximal Reamer/Cannulated Drill | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167480 |
| mdprc 045 11 18 000 | Aroa Biosurgery | OviTex Reinforced BioScaffold | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167628 |
| mdprc 032 11 18 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167380 |
| mdprc 022 11 18 000 | GE Healthcare | Centricity Universal Viewer with PACSIW foundation 6.0.x, entricity PACSIW with Universal Viewer version 5.0.x with PACSIW foundation | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168670 |
| mdprc 021 11 18 000 | Fresenius Kabi Ltd | Volumat MC Agilia | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167772 |
| mdprc 020 11 18 000 | Coltene Whaledent Inc. | ParaPost Plus Posts | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167379 |
| mdprc 019 11 18 000 | Aroa Biosurgery | Endoform Dermal Template | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167603 |
| mdprc 018 11 18 000 | 3M Health Care Ltd | 3M Fast Release Varnish | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166237 |
| mdprc 012 11 18 000 | Philips Healthcare | Vereos PET/CT, Software version 2.0.1. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167661 |
| mdprc 006 11 18 000 | CMP Industries, Llc | IMPAK ELASTIC ACRYLIC RESIN LIQUID | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167770 |
| mdprc 180 10 18 000 | Arrow International Inc | ARROWgard Blue Plus MultiLumen CVC Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167478 |
| mdprc 179 10 18 000 | Custom Healthcare System | CHS Custom Convenience Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167781 |
| mdprc 178 10 18 000 | Magellan Diagnostics Inc | LeadCare II Blood Lead Test Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167389 |
| mdprc 169 10 18 000 | GE Healthcare | Nuclear Magnetic Resonance Imaging | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168339 |
| mdprc 168 10 18 000 | Intuitive Surgical Inc | da Vinci Si Drapes and Disposable Accessory Kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167918 |
| mdprc 167 10 18 000 | Micro-Tech (Nanjing) Co., Ltd | Biopsy Forcept (Alligator with Spike) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167676 |
| mdprc 166 10 18 000 | Nakanishi | Surgical Handpiece | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166437 |
| mdprc 165 10 18 000 | Synthes GmbH | DePuy Synthes 3.0mm Headless Compression Screws | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167574 |
| mdprc 164 10 18 000 | bioMerieux Inc | NucliSENS Magnetic Extraction Reagents | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167420 |
| mdprc 163 10 18 000 | Howmedica Osteonics Corp. | Tritanium TL Steerable Inserter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167441 |
| mdprc 142 10 18 000 | Canon Europa N.V. | Vantage Titan and Vantage Elan MRI Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167258 |
| mdprc 141 10 18 000 | Data Innovations | IM Abbott Alinity ciseries (abdicqii) accessory driver | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167216 |
| mdprc 140 10 18 000 | Smith & Nephew inc | LEGION A/P FEMORAL CUTTING BLOCK | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167446 |
| mdprc 129 10 18 000 | CryoLife, Inc | CryoPatch SG Pulmonary HemiArtery | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167440 |
| mdprc 128 10 18 000 | GE Healthcare | Centricity Universal Viewer 6.0 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168145 |
| mdprc 127 10 18 000 | Medacta International SA | MiniMAX CEMENTLESS ANATOMICAL STEM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167435 |
| mdprc 126 10 18 000 | OriGen Biomedical | OriGen Reinforced Dual Lumen Cannula | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167041 |
| mdprc 125 10 18 000 | Philips Healthcare | HeartStart FR3 Defibrillator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167498 |
| mdprc 124 10 18 000 | Shimadzu Medical Systems | TRINIAS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167416 |
| mdprc 123 10 18 000 | A M Systems Inc | Disposable Smooth Interior Tubing | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167392 |
| mdprc 122 10 18 000 | AS Software, Inc. | ASOBGYN Information System version 7.824.x | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167364 |
| mdprc 121 10 18 000 | Cypress Medical Products. | McKesson Insulin Syringe 0.3mL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167474 |
| mdprc 120 10 18 000 | Life Technologies Limited. | Gibco | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167359 |
| mdprc 118 10 18 000 | Mindray DS USA, Inc., dba Datascope Patient Monitoring | Mindray BeneVision Distributed Monitoring System (DMS) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167424 |
| mdprc 110 10 18 000 | BESMED HEALTH BUSINESS CORP. | Ambu Aura40 Standard | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167221 |
| mdprc 109 10 18 000 | Carl Zeiss Meditec Inc | Carl Ziess Meditec AG IOLMaster 700 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167198 |
| mdprc 086 10 18 000 | Baxter Healthcare | SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167598 |
| mdprc 085 10 18 000 | Beckman Coulter | Access 2 Immunoassay System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146785 |
| mdprc 084 10 18 000 | Cardiovascular Systems, Inc | DIAMONDBACK 360 Peripheral Orbital Atherectomy System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160822 |
| mdprc 083 10 18 000 | Exactech | Tibial Alignment Guide. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166109 |
| mdprc 082 10 18 000 | Helena Biosciences Europe | Free and Total Protein S ELISA Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167256 |
| mdprc 081 10 18 000 | OriGen Biomedical | Reinforced Dual Lumen Cannula, VV13F | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167443 |
| mdprc 080 10 18 000 | Thoratec Corp | Thoratec CentriMag Motor, Model: 102956 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166940 |
| mdprc 079 10 18 000 | Valeris Medical, LLC | Valeris Medical Apollo Medial Suture Anchor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166244 |
| mdprc 077 10 18 000 | Stryker Spine SA | AVS Aria Cage | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167153 |
| mdprc 076 10 18 000 | Widex A/S | WIDEX BABY440 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167425 |
| mdprc 055 10 18 000 | AngioDynamics Inc | BioFlo Port with ENDEXO and PASV Technology | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166933 |
| mdprc 054 10 18 000 | Implant Direct Sybron Manufacturing,LLC | Implant Direct Legacy Implant | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165075 |
| mdprc 053 10 18 000 | Incisive Surgical Inc | INSORB SUBCUTICULAR SKIN STAPLER. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167220 |
| mdprc 052 10 18 000 | Instrumentation Laboratory. | HemosIL ReadiPlasTin. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167053 |
| mdprc 051 10 18 000 | Medline Industries, Inc. | Boot Compression Wrap | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167154 |
| mdprc 050 10 18 000 | Sterilmed | Reprocessed Agilis Steerable Introducer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167197 |
| mdprc 037 10 18 000 | Covidien LLC | Covidien Kerlix AMD, Kerlix, and Dermacea Bandage and Gauze Rolls | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166993 |
| mdprc 036 10 18 000 | Vision RT Ltd | Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167432 |
| mdprc 035 10 18 000 | Beckman Coulter | BECKMAN COULTER MicroScan MICroSTREP Plus Panel,MicroScan MuellerHinton Broth with 3 lysed horse b | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163468 |
| mdprc 034 10 18 000 | Cincinnati Sub-Zero Products Inc | The Hemotherm Dual Reservoir Cooler/Heater | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167066 |
| mdprc 033 10 18 000 | Ellex iScience, Inc. | ellex I.Science iTRACK 250A | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165749 |
| mdprc 032 10 18 000 | Exactech | Equinoxe Reverse Drill Bit Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167190 |
| mdprc 012 10 18 000 | Rayner Intraocular Lenses Ltd | Cflex Intraocular Lens | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167068 |
| mdprc 011 10 18 000 | Intuitive Surgical Inc | da Vinci Si/X/Xi Surgical System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167074 |
| mdprc 010 10 18 000 | Shockwave Medical, Inc. | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166759 |
| mdprc 009 10 18 000 | Swissray | ddR Formula B xray system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167341 |
| mdprc 008 10 18 000 | Tosoh Bioscience Inc | G8 Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165791 |
| mdprc 007 10 18 000 | Ventana Medical Systems | Immunohistochemistry (IHC) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166712 |
| mdprc 006 10 18 000 | Zimmer Biomet, Inc | Juggerknot Long Flex Drill Bit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166941 |
| mdprc 005 10 18 000 | Zimmer, INC | Vanguard 360 Revision Knee System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166904 |
| mdprc 122 09 18 000 | Accuray Inc | Ashland(TM) Box Film Ball Cube II EBT3 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167054 |
| mdprc 121 09 18 000 | Exactech | Optetrak Logic CC Stem Extension, 22mm x 160mm | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166799 |
| mdprc 120 09 18 000 | Medtronic | Temperature sensor catheters | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166446 |
| mdprc 119 09 18 000 | Reckitt Benckiser Healthcare | Durex Real Feel Polyisoprene Condoms | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166702 |
| mdprc 118 09 18 000 | ShinChang Medical Co., Ltd | Disposable Insulin Syringe 0.3mL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167073 |
| mdprc 117 09 18 000 | Arrow International Inc. | Bipolar Electrode Catheter with shrouded pins | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166781 |
| mdprc 116 09 18 000 | Biocare Medical | URO-3 Triple Stain (CD44 + p53) with CK20 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165380 |
| mdprc 115 09 18 000 | Med-Mizer, Inc. | PR1000 Pivot Rehab Bed AC powered adjustable bed. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166687 |
| mdprc 114 09 18 000 | Medtronic | Contour Plus Link 2.4 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166154 |
| mdprc 113 09 18 000 | Swissray | ddR Formula B X-ray System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167170 |
| mdprc 111 09 18 000 | Beaver Visitec International Ltd | Beaver 2-Inch Shaft with Fine Tip Accu-Temp High-Temperature Cautery Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166710 |
| mdprc 110 09 18 000 | MAKO Surgical Corp | Makoplasty RIO Standard System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166807 |
| mdprc 109 09 18 000 | Stryker | IsoFlex LAL Support Surface | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166820 |
| mdprc 108 09 18 000 | Zimmer Biomet, Inc. | Gentle Thread PLGA Full Thread Interference Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166705 |
| mdprc 107 09 18 000 | Bayer Medical Care, Inc. | Overhead Counterpoise Systems (OCS) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166230 |
| mdprc 106 09 18 000 | Cardiovascular Systems, Inc. | Orbital Atherectomy System (OAS) Saline Infusion Pump | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166793 |
| mdprc 105 09 18 000 | Hitachi | VidiStar(TM) PACS & DICOM Viewer Software system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166868 |
| mdprc 104 09 18 000 | Medline Industries Inc. | PICC Tray, Art-Line Surgery Pack-LF, Laparoscopy CDS, Cardiac Insulation Pad and LASER CDS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159473 |
| mdprc 103 09 18 000 | NordicNeuroLab Inc. | fMRI Hardware System VisualSystem | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165672 |
| mdprc 102 09 18 000 | Ohio Medical Corporation | care-e-vac 3 Battery and AC-Powered Portable Aspirators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166447 |
| mdprc 101 09 18 000 | Remel Inc. | THIOGLYCOLLATE MEDIUM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166568 |
| mdprc 100 09 18 000 | SPS Sterilization, Inc. | Multiple Products | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165305 |
| mdprc 099 09 18 000 | Zimmer Biomet, Inc. | Peg Fully Threaded | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166235 |
| mdprc 098 09 18 000 | Vascular Technology, Inc. | VTI 8 MHz Surgical Doppler | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165673 |
| mdprc 097 09 18 000 | Sysmex America Inc (N/A) | Sysmex Fluorocell PLT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166208 |
| mdprc 096 09 18 000 | Medline Industries Inc. | Medline 0.9 Sodium Chloride Injection | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166187 |
| mdprc 095 09 18 000 | DePuy International Limited | P.F.C. SIGMA Revision Knee System Distal Augment | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166108 |
| mdprc 063 09 18 000 | C R Bard Inc | Urine Collection BARD Midstream Catch Kit with Funnel Connector | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165908 |
| mdprc 062 09 18 000 | Medtronic SA | TurboHawk Peripheral Plaque Excision Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166684 |
| mdprc 061 09 18 000 | Stanbio Laboratory, LP | Power adapter for the HemoPoint H2 meter, Model G3000 series | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165739 |
| mdprc 014 09 18 000 | Arrow International Inc | ARROW Pediatric TwoLumen Central Venous Catheterization Kit with Blue FlexTip ARROWgard Blue Cathe | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165939 |
| mdprc 013 09 18 000 | bioMerieux Inc | VITEK 2 Gram Positive, Cefoxitin Screen and AST for Oxacillin | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165899 |
| mdprc 012 09 18 000 | Johnson & Johnson Vision Care | Johnson and Johnson Vision Care 1 Day ACUVUE MOIST | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166086 |
| mdprc 011 09 18 000 | Smith & Nephew inc | GENESIS II NONPOROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166265 |
| mdprc 090 08 18 000 | Vyaire Medical, Inc.. | TriFlo Subglottic Suction System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165645 |
| mdprc 089 08 18 000 | Ortho Kinematics, Inc | Vertebral Motion Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166147 |
| mdprc 088 08 18 000 | LIEBEL-FLARSHEIM COMPANY LLC | LiebelFlarsheim Hydra Vision Urology XRay System (DR) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164768 |
| mdprc 087 08 18 000 | In2Bones, SAS | CoLink(TM) Lapidus Plate XP | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165897 |
| mdprc 086 08 18 000 | Back 2 Basics Direct LLC | Dymaxeon Spine System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165987 |
| mdprc 085 08 18 000 | Compass Health Brands | CPAP Mask Cushion | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165713 |
| mdprc 084 08 18 000 | Philips Healthcare | philips DigitalDiagnost 2.x | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165967 |
| mdprc 083 08 18 000 | ICU Medical de Mexico, S.A. | Ext Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165537 |
| mdprc 082 08 18 000 | Zimmer Biomet, Inc. | ECHO BiMetric Hip System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165699 |
| mdprc 081 08 18 000 | Zimmer Biomet, Inc. | ECHO BiMetric and ARCOS Modular Revision Hip System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165699 |
| mdprc 080 08 18 000 | Withings Sas | Blood Pressure Monitor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165696 |
| mdprc 079 08 18 000 | TriMed | Ulnar Osteotomy Compression Plate, Short | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165588 |
| mdprc 078 08 18 000 | Nico Corp | NICO Shepherds Hook Greenberg | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165708 |
| mdprc 077 08 18 000 | Hitachi America, Ltd. | Hitachi Scenaria CT system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166120 |
| mdprc 076 08 18 000 | DRG Instruments GmbH | Z-2836-2018 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165759 |
| mdprc 075 08 18 000 | Cypress Medical Products. | McKesson Powder Free Vinyl Exam Gloves | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166117 |
| mdprc 074 08 18 000 | bioMerieux Inc | bioMrieux VITEK 2 NH ID Test Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165596 |
| mdprc 073 08 18 000 | Becton Dickinson & Co. (BD) | BD BBL GCLect Agar | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165757 |
| mdprc 053 08 18 000 | Vitalgo Inc | VitalGo Total Lift Bed | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165601 |
| mdprc 052 08 18 000 | Tosoh Bioscience Inc | G8 Automated HPLC Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164973 |
| mdprc 051 08 18 000 | Mevion Medical Systems, Inc. | MEVION S250/MEVION S250i | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165886 |
| mdprc 050 08 18 000 | GUANGZHOU Wondfo Biotech Co., Ltd. | TCube One Step MultiDrug Oral Fluid Test Cube | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165501 |
| mdprc 049 08 18 000 | Cook Endoscopy | VentriClear | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165597 |
| mdprc 048 08 18 000 | Beaver Visitec International Ltd | Beaver Xstar | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165742 |
| mdprc 047 08 18 000 | Water Pik, Inc | Sonic-Fusion Flossing Toothbrushes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165720 |
| mdprc 046 08 18 000 | Spacelabs Healthcare Inc | Arkon Anesthesia Delivery System.. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165550 |
| mdprc 045 08 18 000 | Hudson Scientific LLC | iTOVi Tracker/Scanner | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165574 |
| mdprc 044 08 18 000 | Howmedica Osteonics Corp. | rHead, Lateral Assembly and multiple Orthopedic implants | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161897 |
| mdprc 043 08 18 000 | Boston Scientific Cardiac Rhythm Management Group | Boston Scientific Guider Softip XF Guide Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165651 |
| mdprc 042 08 18 000 | Think Surgical, Inc. | Think Surgical Cutter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164544 |
| mdprc 027 08 18 000 | Tandem Diabetes Care Inc | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163813 |
| mdprc 023 08 18 000 | Baxter | AMIA Automated PD Cycler | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165664 |
| mdprc 022 08 18 000 | Encore Medical, Lp | Instrument trays used to store AltiVate Small Shell Trials | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165508 |
| mdprc 021 08 18 000 | Medtronic SA | CD HORIZON Solera Spinal System Screws | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165709 |
| mdprc 020 08 18 000 | New Era Orthopaedics, LLc | Modera Modular Pedicle Screw System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165627 |
| mdprc 011 08 18 000 | Envoy Medical Corporation | Final Pack, Esteem II, Sound Processor Model 2001 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165600 |
| mdprc 008 08 18 000 | Arrow International Inc | Arrow Percutaneous Sheath Introducer Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165304 |
| mdprc 153 07 18 000 | Terumo Cardiovascular Systems Corporation | Cardiovascular Procedure Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165032 |
| mdprc 152 07 18 000 | LivaNova PLC | VNS Therapy Programming System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165408 |
| mdprc 150 07 18 000 | CryoLife, Inc. | BioGlue Surgical Adhesive. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165020 |
| mdprc 149 07 18 000 | Cayenne Medical Inc. | Quattro Spade Drill | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165400 |
| mdprc 140 07 18 000 | Bio-Rad Laboratories Inc | BioRad PR 4100 Microplate Reader | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165373 |
| mdprc 139 07 18 000 | Cayenne Medical Inc. | AperFix Femoral Implant Coring Removal Drill | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165389 |
| mdprc 138 07 18 000 | Forte Automation Systems Inc | PATIENT POSITIONING SYSTEM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165646 |
| mdprc 137 07 18 000 | Life Technologies Limited. | Gibco Dulbecco's Modified Eagle Medium (DMEM) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165365 |
| mdprc 136 07 18 000 | OMNIlife science | OMNI Hip System, ApeXLNK Acetabular Inserts | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165379 |
| mdprc 135 07 18 000 | Tactical Medical Solutions | BLAST Bandage | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164712 |
| mdprc 132 07 18 000 | Clarity Diagnostics Llc | Clarity Urocheck 10SG Urinalysis Strips | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165700 |
| mdprc 131 07 18 000 | Ethicon Inc. | PDS" Plus Antibacterial Suture, PDS" II (Polydioxanoe) Suture Dyed & Undyed | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165371 |
| mdprc 130 07 18 000 | The Brewer Company, LLC | Access HiLow Exam Tables, Model 6501XX | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164734 |
| mdprc 127 07 18 000 | Siemens Medical Solutions | Artis zee and AXIOM Artis systems with Laird Cooling Unit for SSFD | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165671 |
| mdprc 120 07 18 000 | Carl Zeiss Meditec Inc | Zeiss Celldiscoverer 7 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165394 |
| mdprc 119 07 18 000 | Medtronic SA | Visualase Cooled Laser Applicator System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165572 |
| mdprc 118 07 18 000 | Philips Healthcare | Ingenuity Digital PET/CT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165369 |
| mdprc 105 07 18 000 | Ethicon Inc. | D-Special PROLENE Polypropylene and D-Special PRONOVA Hexafluoropropylene-VDF Sutures | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165105 |
| mdprc 104 07 18 000 | Fx Solutions | Fx SOLUTIONS CENTERED HEAD | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165089 |
| mdprc 116 02 18 001 | PENTAX Europe GmbH | Pentax Video Duodenoscope | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00887-1 |
| mdprc 094 07 18 000 | Integra LifeSciences | The UNICP bone fixation system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165161 |
| mdprc 093 07 18 000 | Intel-GE Care Innovations LLC | Health Harmony Mobile | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165321 |
| mdprc 090 07 18 000 | Canadian Hospital Specialties | MEDRX, Ref 541650R 5Fr X 16" (40cm) Polyurethane Feeding Tube For Pediatric Use | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165293 |
| mdprc 089 07 18 000 | Edwards Lifesciences | Edwards SAPIEN 3 Transcatheter Heart Valve (THV) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165357 |
| mdprc 088 07 18 000 | Medtronic SA | Vectris SureScan and Vectris Trial Screening Lead Kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164967 |
| mdprc 087 07 18 000 | Opgen Inc | AdvanDx QuickFISH Slides | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165084 |
| mdprc 086 07 18 000 | QIAGEN Inc | AmniSure ROM Test | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165377 |
| mdprc 085 07 18 000 | Valeris Medical, LLC | Apollo XT Suture Anchors | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164354 |
| mdprc 079 07 18 000 | Anika Therapeutics Inc. | Hyalomatrix | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165068 |
| mdprc 078 07 18 000 | Dako Denmark A/S | PDL1 IHC 22C3 pharmDx | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162750 |
| mdprc 074 07 18 000 | Cayenne Medical Inc. | AperFix Femoral Implant | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165033 |
| mdprc 073 07 18 000 | Fort Defiance Industries, LLC | P2131 AUTOMATED FIELD STEAM STERILIZER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165069 |
| mdprc 072 07 18 000 | Immuno-Mycologics, Inc. (IMMY) | Cryptococcal Antigen Lateral Flow Assays. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165046 |
| mdprc 071 07 18 000 | Ohio Medical Corporation | PushToSet Intermittent Suction Units | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165072 |
| mdprc 069 07 18 000 | STERIS Corporation | Reliance 1227 Cart and Utensil Washer/Disinfector | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164966 |
| mdprc 059 07 18 000 | Arrow International Inc | VPS Rhythm ECG , VPS Rhythm ECG , Peripherally Inserted Midline Catheter Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165078 |
| mdprc 058 07 18 000 | Medline Industries, Inc. | BARD MYPICC Kit, REF CK000095B | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164837 |
| mdprc 057 07 18 000 | Zimmer Biomet, Inc. | Zimmer M/L Taper Hip Prosthesis | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164815 |
| mdprc 043 07 18 000 | Trilliant Surgical Ltd | Cannulated Driver Handles | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164836 |
| mdprc 037 07 18 000 | B Braun Medical Inc | 26Lead Transfer Set for use with APEX Compounding System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164915 |
| mdprc 031 07 18 000 | Beaver Visitec International Ltd | Safety Sideport Knife | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165153 |
| mdprc 010 07 18 001 | Philips Healthcare | Philips Ingenuity Core128/Elite China 728324 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164781 |
| mdprc 011 07 18 000 | Ion Beam Applications S.A. | Proton Therapy System Proteus 235 (brand names: Proteus Plus and Proteus ONE) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164898 |
| mdprc 009 07 18 000 | Safe N Simple, LLC | Safe N Simple NoSting Skin Barrier Film | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164916 |
| mdprc 008 07 18 000 | St. Jude Medical Inc | Merlin PCS Programmer Software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164947 |
| mdprc 005 07 18 000 | Cenorin | HLD Systems 600 Series Washer/Pasteurizer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165073 |
| mdprc 004 07 18 000 | KONICA MINOLTA, INC | Panasonic Toughbook CF-C2 and CF-SX Laptops | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164903 |
| mdprc 003 07 18 000 | Olympus | Model PJF-160 Duodenoscopes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164186 |
| mdprc 121 06 18 000 | Exsurco Medical | Amalgatome SD | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165083 |
| mdprc 120 06 18 000 | Intersurgical Limited | Intersurgical Breathing Circuit 22mm, nonconductive, single patient use | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164961 |
| mdprc 119 06 18 000 | Ion Beam Applications S.A. | ProteusPLUS and ProteusONE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165077 |
| mdprc 116 06 18 000 | B. BRAUN MEDICAL INC | Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164671 |
| mdprc 115 06 18 000 | HORIBA ABX SAS. | ABX Pentra Micro ALBUMIN 2 CP | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164230 |
| mdprc 114 06 18 000 | Teleflex Medical | Pilling(R) UNIVERSAL SHEARS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165023 |
| mdprc 113 06 18 000 | Zimmer Biomet, Inc. | Various Trauma Guidewires | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164833 |
| mdprc 105 06 18 000 | Cyberonics Inc | Model 3000 VNS Therapy Programmers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164316 |
| mdprc 104 06 18 000 | Paragon 28, Inc | Drill guide for the JAWS Nitinol Staple System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164789 |
| mdprc 093 06 18 000 | Safe N Simple, LLC | Simpurity DermaPro Waterproof Silicone Tape, Safe'n'Simple, WOUNDCARE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164922 |
| mdprc 092 06 18 000 | Synthes GmbH. | Graphic Case 6.5mm & 7.3mm Cannulated Screw Sets | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163239 |
| mdprc 091 06 18 000 | Zimmer Biomet, Inc. | Biomet Modular Primary Tibial Tray Implants (size 75 mm) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164798 |
| mdprc 083 06 18 000 | AngioDynamics Inc | BioFlo PICC (NV) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164762 |
| mdprc 082 06 18 000 | C2 Therapeutics Inc. | Catheter, C2 CryoBalloon" Ablation System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164786 |
| mdprc 062 06 18 000 | Philips Healthcare | Brilliance 16 P, Brilliance 16 and Brilliance 64 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164549 |
| mdprc 061 06 18 000 | bioMerieux Inc | The VITEK 2, The PREVI, VIDAS TOXO IgG, Color Gram 2 and Oxidase Reagent | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164591 |
| mdprc 060 06 18 000 | Baxter Healthcare | SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164215 |
| mdprc 059 06 18 000 | Carl Zeiss Meditec Inc | Carl Zeiss Microscopy for Laser Scanning Microscopes (Cell Observer SD, Laser TIRF and DirectFRAP) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164575 |
| mdprc 058 06 18 000 | Fresenius Medical Care. | NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164557 |
| mdprc 057 06 18 000 | IBA Dosimetry GmbH | 12C, Proteus ONE and Proteus Plus | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164905 |
| mdprc 056 06 18 000 | IBA Dosimetry GmbH | 12C (AdaPTinsight) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164900 |
| mdprc 055 06 18 000 | Keystone Industries t/a Harry J. Bosworth Company | Prima Plus 4.1 x 11.5mm Implant | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164567 |
| mdprc 054 06 18 000 | Maquet Cardiopulmonary AG | Aortic Arterial Cannula 20, 22 and 24 Fr | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164362 |
| mdprc 053 06 18 000 | Smiths Medical International Limited | Bivona Tracheostomy Tube Tracheostomy Tubes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164546 |
| mdprc 052 06 18 000 | Thermo Fisher Scientific Inc. | remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164353 |
| mdprc 051 06 18 000 | Zimmer Biomet, Inc. | ROSA Robotized Stereotactic Assistant, Version 2.5 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164315 |
| mdprc 026 06 18 000 | VGI Medical, LLC | VerteLP Instrument Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164210 |
| mdprc 025 06 18 000 | Tosoh Bioscience Inc | STAIA PACK | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163500 |
| mdprc 024 06 18 000 | NordicNeuroLab AS | fMRI Hardware System AudioSystem, Version 1.0 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160719 |
| mdprc 023 06 18 000 | C R Bard Inc | Bardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164685 |
| mdprc 020 06 18 000 | Randox Laboratories Ltd. | RX Imola | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164051 |
| mdprc 019 06 18 000 | NordicNeuroLab AS | nordicICE v 2.3.14 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159628 |
| mdprc 009 06 18 000 | Stryker Communications | DRILOK THREADED CANNULA | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164124 |
| mdprc 008 06 18 000 | SANTA JOY ORNAMENT & GIFTWARE CO | EZ Illuminations Northern Lights EZ Illuminations Galaxy | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160993 |
| mdprc 007 06 18 000 | NordicNeuroLab AS | nordicBrainEX | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164721 |
| mdprc 006 06 18 000 | Medical Action Industries Inc | Medical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per Pack) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164683 |
| mdprc 005 06 18 000 | Ii-Vi Incorporated | NonCertified laser diode component | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164228 |
| mdprc 004 06 18 000 | Hobbs Medical, Inc | Hobbs Bronchial Cytology Brushes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163898 |
| mdprc 003 06 18 000 | Arrow International Inc | Multible Catheter, percutaneous, Needls | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163837 |
| mdprc 002 06 18 000 | WRP ASIA PACIFIC SDN BHD | AmerisourceBergen Sterile Latex Surgical Gloves, Powder Free | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164146 |
| mdprc 001 06 18 000 | Philips Healthcare | HeartStart MRx Monitor/Defibrillator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164128 |
| mdprc 146 05 18 000 | Respire Medical | Respire Pink Hard/Soft | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164720 |
| mdprc 145 05 18 000 | Genesee BIOMEDICAL, INC. | Sternal Valve Retractors with Atrial and Aortic Attachments | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164233 |
| mdprc 144 05 18 000 | Dynarex Corporation | Dynarex CGA870 All Brass Oxygen RegulatorAll Brass 025 LPM, Barb & 2DISS Outlet | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164303 |
| mdprc 143 05 18 000 | Cook Medical Europe Limited | MINC Benchtop Incubators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163146 |
| mdprc 139 05 18 000 | Symmetry Surgical | SYMMETRY Olsen Single-Use Electrocautery Forceps, Pencils, and Cords | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164447 |
| mdprc 138 05 18 000 | Siemens Healthcare Diagnostics Product | Syva Emit 2000 Theophylline Assay | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162253 |
| mdprc 137 05 18 000 | Medline Industries Inc | Needle Counters | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164217 |
| mdprc 136 05 18 000 | Siemens Medical Solutions | Siemens Biograph Horizon | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164356 |
| mdprc 135 05 18 000 | Baxter Healthcare | Prismaflex Control Units | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164046 |
| mdprc 134 05 18 000 | Baxter Healthcare | EXACTAMIX Inlets | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164079 |
| mdprc 118 05 18 000 | LivaNova USA | INSPIRE 6 and INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163774 |
| mdprc 117 05 18 000 | Smith & Nephew inc | 5o (degree) GENESIS(R) II VALGUS BUSHING | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163785 |
| mdprc 116 05 18 000 | Spinal Elements | AMENDIA Omega Lumbar Interbody Fusion Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163816 |
| mdprc 115 05 18 000 | Synthes GmbH. | Synthes Torque Limiting Handle | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164278 |
| mdprc 114 05 18 000 | Teleflex Medical | Teleflex MEDICAL LMA(TM) MADgic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162883 |
| mdprc 101 05 18 000 | Beckman Coulter | iChem(R) VELOCITY Urine Chemistry Strips | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163764 |
| mdprc 100 05 18 000 | Southmedic Inc | Southmedic Sterile Disposable Scalpel Rx only | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164365 |
| mdprc 099 05 18 000 | VOLCANO CORPORATION | Philips Volcano Core M2Imaging Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163160 |
| mdprc 094 05 18 000 | Coltene Whaledent Inc. | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164149 |
| mdprc 093 05 18 000 | ConvaTec | Convatec Esteem(TM) Synergy Stomahesive(R) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164023 |
| mdprc 088 05 18 000 | CooperSurgical Inc | Fischer Cone Biopsy Excisor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163620 |
| mdprc 087 05 18 000 | Epic Extremity, LLC | Epic Extremity Plate System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163592 |
| mdprc 086 05 18 000 | Micro-Tech (Nanjing) Co., Ltd | Trident Endoscopic Ultrasonic Aspiration Needle (FNA) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163919 |
| mdprc 085 05 18 000 | Nipro Medical Corporation | Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163665 |
| mdprc 082 05 18 000 | Draeger Medical Systems Inc | Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163782 |
| mdprc 081 05 18 000 | Kelyniam Global, Inc. | Kelyniam CSI | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163449 |
| mdprc 080 05 18 000 | Rockwell Medical, Inc | DriSate | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163799 |
| mdprc 079 05 18 000 | Tosoh Bioscience Inc | Tosoh ST AIAPACK HbA1c Calibrator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163114 |
| mdprc 078 05 18 000 | Bard Pcripheral Vascular (BPV) | POWERPORT(R) ClearVUE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163713 |
| mdprc 077 05 18 000 | ICU Medical, Inc | Hemodynamic Monitoring System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163535 |
| mdprc 076 05 18 000 | Medtronic SA | Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163451 |
| mdprc 075 05 18 000 | Ninepoint Medical Inc. | NvisionVLE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163810 |
| mdprc 074 05 18 000 | Parker Laboratories, Inc | Sterile Aquasonic 100 Ultrasound Transmission Gel | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163914 |
| mdprc 073 05 18 000 | Siemens Medical Solutions | Syngo.Via VB20A model 1049610 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163815 |
| mdprc 064 05 18 000 | Beaver Visitec International Ltd | WetField Hemostatic Eraser Bipolar 25G | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163934 |
| mdprc 063 05 18 000 | C R Bard Inc | SEEKER(R) Crossing Support Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163824 |
| mdprc 062 05 18 000 | Inpeco S.A. | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162888 |
| mdprc 061 05 18 000 | Ondamed Inc | Ondamed Biofeedback Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163767 |
| mdprc 060 05 18 000 | TP Orthodontics Inc. | Jasper Vektor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163879 |
| mdprc 059 05 18 000 | Vyaire Medical | Resuscitation Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163362 |
| mdprc 050 05 18 000 | Zimmer Biomet, Inc. | LactoSorb RapidFlap Spindown Instruments | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164133 |
| mdprc 049 05 18 000 | Microline Surgical Inc. | ReNew brand Disposable Scissor and Dissector Tips | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162315 |
| mdprc 048 05 18 000 | DePuy International Ltd | LATARJET EXPERIENCE Sharp Curved Ostetome | FAROUK, MAAMOUN TAMER & COMPANY |
| mdprc 047 05 18 000 | Datascope Corp | Custom Tubing Pack with Bioline Coating. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163787 |
| mdprc 034 05 18 000 | Vygon UK Ltd | PICC Insertion Tray | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163553 |
| mdprc 033 05 18 000 | Straumann Manufacturing, Inc. | Straumann Emdogain | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163233 |
| mdprc 032 05 18 000 | Siemens Medical Solutions | Syngo Plaza | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163390 |
| mdprc 029 05 18 000 | Conseal International, Inc. | Nanosil Spray Gel | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164041 |
| mdprc 028 05 18 000 | IntroMedic Co., Ltd. | MiroCam Capsule Endoscope Syste | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163624 |
| mdprc 027 05 18 000 | PerkinElmer Life and Analytical Sciences | NeoBase Succinylacetone Assay Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161848 |
| mdprc 021 05 18 000 | Beijing Syntech Laser Co., Ltd | Laser Handpiece | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163046 |
| mdprc 020 05 18 000 | Stryker Communications Corp | 6381 M1 and 6376 M1 Cot Fastener | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163576 |
| mdprc 019 05 18 000 | DeRoyal Industries Inc. | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163991 |
| mdprc 018 05 18 000 | CooperSurgical Inc. | Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163601 |
| mdprc 011 05 18 000 | Cardinal-Health | MediVac(TM) Flex Advantage(TM) Suction Canister Liner | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163108 |
| mdprc 158 04 18 000 | Accelerate Diagnostics Inc | Accelerate PhenoTest BC kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162852 |
| mdprc 157 04 18 000 | Beaver Visitec International Ltd | WETFIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163908 |
| mdprc 156 04 18 000 | PerkinElmer Life and Analytical Sciences | Specimen Gate Screening Center Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162274 |
| mdprc 155 04 18 000 | Polymer Technology Systems, Inc | PTS Panels CHOLGLU Test Strips | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163394 |
| mdprc 150 04 18 000 | Ethicon Inc | Evicel Accessory Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162948 |
| mdprc 149 04 18 000 | HEIDELBERG ENGINEERING GmbH | Widefield OCT software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162348 |
| mdprc 148 04 18 000 | Menarini Silicon Biosystems | CELLSEARCH Circulating Tunor Cell Kit (Epithelial) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163784 |
| mdprc 147 04 18 000 | Smith & Nephew | WHIPKNOT Soft Tissue Cinch | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163060 |
| mdprc 146 04 18 000 | Stryker Europe | Hinge Coupling Hoffmann LRF | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163236 |
| mdprc 145 04 18 000 | Zimmer Biomet, Inc. | Biomet Hip System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162993 |
| mdprc 138 04 18 000 | Cook Medical Europe Limited | Advance 35LP LowProfile PTA Balloon Dilatation Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163783 |
| mdprc 137 04 18 000 | Roche Diagnostics Corp | Enzymatic assay for the determination of Acetaminophen | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162582 |
| mdprc 136 04 18 000 | Zimmer Biomet, Inc. | Orthopedic Salvage System Modular Arthrodesis Nail 0° Collar Assemblies with Locking Bolts | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163021 |
| mdprc 126 04 18 000 | NeuroLogica | GMR40 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162862 |
| mdprc 125 04 18 000 | Siemens Medical Solutions | MEVATRON , ONCOR , PRIMUS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163344 |
| mdprc 124 04 18 000 | Crimson Trace Corporation | CTC laser sights | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162939 |
| mdprc 123 04 18 000 | Keystone Dental Inc. | Genesis Surgical Cassette Tapered | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163234 |
| mdprc 122 04 18 000 | Stryker Instruments | Stryker Toga | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163400 |
| mdprc 142 03 18 001 | ConMed Corporation. | PadPro MiniInfant Multifunction Electrodes 2602 Series | FDA and BfArM |
| mdprc 108 04 18 000 | Ace Surgical Supply Co., Inc | Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163464 |
| mdprc 107 04 18 000 | Cook Medical | Cook Vacuum Pump | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163165 |
| mdprc 106 04 18 000 | Integra LifeSciences | TITAN | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162744 |
| mdprc 105 04 18 000 | Life Technologies Limited. | Oncomine Dx Target Test. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162895 |
| mdprc 104 04 18 000 | Terumo Cardiovascular Systems Corporation | Terumo Advanced Perfusion System 1 Flow Module. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162847 |
| mdprc 103 04 18 000 | TMJ Solutions Inc | TMJ Concepts PatientFitted TMJ Reconstruction Prosthesis System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162774 |
| mdprc 089 04 18 000 | Autochair | Milford Smartbase | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162854 |
| mdprc 088 04 18 000 | Halyard Health Co. | Halyard Health Closed Suction Kits with Flex Connector | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162853 |
| mdprc 087 04 18 000 | Philips Healthcare | Nuclear, Magnetic Resonance Imaging | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162712 |
| mdprc 086 04 18 000 | Draeger Medical Systems Inc | Infinity Acute Care System (lACS) Monitoring Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162928 |
| mdprc 085 04 18 000 | Preservation Solutions, Inc | Belzer UW & Waters IGL Cold Storage Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162159 |
| mdprc 084 04 18 000 | Southern Implants, Inc | Implant, Ext. Hex, tapered 12o CoAxis | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162906 |
| mdprc 083 04 18 000 | Zimmer Biomet, Inc | 38 mm Offset Segmental System Proximal Femoral Components | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162988 |
| mdprc 077 04 18 000 | Fresenius Medical Care | Liberty Select Cycler | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162848 |
| mdprc 076 04 18 000 | Tornier Inc | Phantom Fiber Biofiber Sutures | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162146 |
| mdprc 075 04 18 000 | Bard Pcripheral Vascular (BPV) | Nasogastric Sump Tubes with ENFit Connector | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162514 |
| mdprc 074 04 18 000 | Certified Safety Mfg Inc | First aid/emergency kits containing Honeywell eyewash | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162951 |
| mdprc 073 04 18 000 | The Magstim Company Limited | Rapid2 Therapy System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162681 |
| mdprc 072 04 18 000 | Orthofix | ORTHOFIX, Connector System, SMALL and LARGE SET SCREW | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162480 |
| mdprc 069 04 18 000 | Arrow International Inc | Multible Introducers and Catheters | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162552 |
| mdprc 068 04 18 000 | Ethicon Inc. | PDS Plus Antibacterial monofilament syntheticabsorbable sutures | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162610 |
| mdprc 066 04 18 000 | ICU Medical, Inc | Smallbore Ext Set w/MicroClave, Clave TConnector, Clamp, Rotating Luer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161287 |
| mdprc 065 04 18 000 | Nidek Inc. | AUTO REF/KERATOMETER ARK1s | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162625 |
| mdprc 064 04 18 000 | Reliance Medical Products. | Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162749 |
| mdprc 063 04 18 000 | Shenzhen Mindray | M-30D Diluent used with BC-3200 and BC-3600 Auto Hematology Analyzers , Hematology Diluent M-53D used with BC-5390 Hematology Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162631 |
| mdprc 052 04 18 000 | Lifeline Systems, Incorporated | HomeSafe AutoAlert Pendant, AAHB, or AutoAlert Fall Detector | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161078 |
| mdprc 051 04 18 000 | Phadia Ltd | ImmunoCAP Allergen c6, Amoxicilloyl | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162339 |
| mdprc 050 04 18 000 | Philips Burton | Intellivue X3 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160242 |
| mdprc 049 04 18 000 | Smith & Nephew inc | DRAD SelfTapping Locking Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162539 |
| mdprc 048 04 18 000 | Terumo Cardiovascular Systems Corporation | Cardiovascular Procedure Kits, Tubing Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162581 |
| mdprc 032 04 18 000 | Magellan Diagnostics Inc | LeadCare Plus and LeadCare II Blood Lead Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161822 |
| mdprc 031 04 18 000 | Siemens Medical Solutions | Syngo.via. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162599 |
| mdprc 030 04 18 000 | Zimmer Biomet, Inc. | A.L.P.S. MinimallyInvasive (MIS) and Mesh Calcaneus Plating System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162202 |
| mdprc 027 04 18 000 | Seiler Instrument & Manufacturing Inc, Co | Alpha Air 6 ENT Microscope | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162123 |
| mdprc 026 04 18 000 | Fresenius Medical Care. | 2008 Series Hemodialysis Machine | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162434 |
| mdprc 025 04 18 000 | Ion Beam Applications S.A. | Proteus 235 Proton Therapy Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161705 |
| mdprc 024 04 18 000 | Medical Components, Inc | 8F Plastic Dignity Low Profile CT Port | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162340 |
| mdprc 023 04 18 000 | Medtronic SA | 6F Taiga Guiding Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162346 |
| mdprc 022 04 18 000 | Mesa Laboratories, Inc. | SporAmpule Biological Indicator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162162 |
| mdprc 021 04 18 000 | SIE AG, Surgical Instrument Engineering | FEMTO LDV(TM)Z8 Femtosecond Surgical Laser | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162149 |
| mdprc 008 04 18 000 | Allen Medical Systems | Trumpf Medical T3 Spinal Tabletop Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162773 |
| mdprc 007 04 18 000 | Arrow International Inc | ARROW ENDURANCE" Extended Dwell Peripheral Catheter System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162429 |
| mdprc 006 04 18 000 | Deerfield Imaging | IMRIS ORT300 Removable Operating Room Table | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162137 |
| mdprc 005 04 18 000 | Encore Medical, Lp | AltiVate Reverse, HUMERAL SOCKET SHELL TRIAL, STANDARD | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162109 |
| mdprc 004 04 18 000 | Roche Diagnostics Corp | cobas c 6000 MODULAR Series System e 601 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161278 |
| mdprc 003 04 18 000 | Siemens Medical Solutions | Syngo.via software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162538 |
| mdprc 002 04 18 000 | Zimmer Biomet, Inc. | Phoenix Nail System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162454 |
| mdprc 001 04 18 000 | Zimmer Biomet, Inc. | PERSONA THE PERSONALIZED KNEE SYSTEM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162203 |
| mdprc 154 03 18 000 | Cook Medical Europe Limited | Norm-Ject Tuberkulin Syringes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162423 |
| mdprc 153 03 18 000 | GE Healthcare | Tec 7 Vaporizer, Aisys CS2 Aladin Cassette | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162478 |
| mdprc 152 03 18 000 | Madison Polymeric Engineering | First Step Flexible Endoscope Bedside PreClean Kit, EP4. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162225 |
| mdprc 151 03 18 000 | Ohmeda Medical | Rotating IV Pole | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162347 |
| mdprc 150 03 18 000 | Quidel Corporation | Sofia 2 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161800 |
| mdprc 141 03 18 000 | Zimmer Biomet, Inc. | Comprehensive Segmental Revision System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162212 |
| mdprc 140 03 18 000 | GETINGE US SALES LLC | HEMASHIELD Knitted Double Velour Cardiovascular Fabric | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162603 |
| mdprc 139 03 18 000 | Circulatory Technology Inc | BetterBladder | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162626 |
| mdprc 138 03 18 000 | Becton Dickinson & Co. (BD) | BD Vacutainer EDTA Tubes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161776 |
| mdprc 137 03 18 000 | Beckman Coulter | AutoMate 2500 Family | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161071 |
| mdprc 136 03 18 000 | Arrow International Inc | ARROW, ARROWGARD AND ARROWGARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162075 |
| mdprc 123 03 18 000 | Arrow International Inc | ARROWgard Blue PLUS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162585 |
| mdprc 122 03 18 000 | Bovie Medical Corporation | J-Plasma Handpieces | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162211 |
| mdprc 121 03 18 000 | Ethicon Inc. | Dermabond " Prineo " System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162112 |
| mdprc 120 03 18 000 | Medica Corporation. | Chemistry Wash1 REF 10680 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161792 |
| mdprc 119 03 18 000 | Vascular Insights, LLC | ClariVein IC infusion catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161969 |
| mdprc 115 03 18 000 | Merit Medical Systems, Inc | Custom Dialysis Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162332 |
| mdprc 111 03 18 000 | CooperSurgical Inc | 2 MHZ Waterproof OB Probe | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161662 |
| mdprc 110 03 18 000 | HYPHEN BioMed | ZYMUTEST HIA IgGAM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161801 |
| mdprc 109 03 18 000 | IRIDEX Corporation | Laser Indirect Ophthalmoscope (LIO) . | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162191 |
| mdprc 108 03 18 000 | Medical Components, Inc | REPAIR KIT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162326 |
| mdprc 107 03 18 000 | OMNIlife science | Apex Knee System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161796 |
| mdprc 106 03 18 000 | Smith & Nephew inc | LEGION HK FEMORAL WEDGE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161747 |
| mdprc 105 03 18 000 | Smiths Medical ASD Inc | Power PORTACATH | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162308 |
| mdprc 104 03 18 000 | Stanbio Laboratory, LP | RF Latex Reagent | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161742 |
| mdprc 103 03 18 000 | Zimmer Biomet, Inc. | Cannulated Screw System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162192 |
| mdprc 096 03 18 000 | Zimmer Biomet, Inc. | Comprehensive Shoulder System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162190 |
| mdprc 095 03 18 000 | Zimmer Biomet, Inc. | Vanguard Complete Knee System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161749 |
| mdprc 094 03 18 000 | Zimmer Biomet, Inc. | SnapShot" Fixation System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161802 |
| mdprc 093 03 18 000 | Zimmer Biomet, Inc. | Ringloc CoCr Modular Femoral Heads | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161757 |
| mdprc 092 03 18 000 | Zimmer Biomet, Inc. | NEXGEN LPSFLEX MOBILE AND LPSMOBILE BEARING KNEE SYSTEM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162418 |
| mdprc 091 03 18 000 | Zimmer Biomet, Inc. | JUGGERKNOT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161740 |
| mdprc 090 03 18 000 | Fresenius Medical Care | NaturaLyte Liquid Acid | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161727 |
| mdprc 089 03 18 000 | Alden Optical | Alden Soft contact | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162157 |
| mdprc 072 03 18 000 | Roche Diagnostics Corp | cobas 6000, cobas 8000 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161418 |
| mdprc 071 03 18 000 | Medimop Medical Projects Ltd. | Via2BagDirect Connect | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161741 |
| mdprc 070 03 18 000 | Laerdal Medical As | APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161566 |
| mdprc 063 03 18 000 | Abbott Point of Care | iSTAT DE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161446 |
| mdprc 062 03 18 000 | Becton Dickinson & Co. (BD) | Difco Agar Noble, 500g bottle | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161669 |
| mdprc 061 03 18 000 | Cook Medical | Heparin-Coated Guidewires and Catheter Sets | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161581 |
| mdprc 060 03 18 000 | Ion Beam Applications S.A. | ProteusONE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161706 |
| mdprc 059 03 18 000 | Ion Beam Applications S.A. | ProteusONE and ProteusPLUS Proteus 235 Proton Therapy Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161709 |
| mdprc 058 03 18 000 | Ion Beam Applications S.A. | Proteus 235 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161689 |
| mdprc 057 03 18 000 | Zimmer inc | Trabecular Metal Primary Hip Prosthesis | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162208 |
| mdprc 056 03 18 000 | Z-Medica LLC | QuikClot Trauma Pad | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162235 |
| mdprc 047 03 18 000 | Covidien LLC | staple, implantable, Endo GIA | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161502 |
| mdprc 046 03 18 000 | Ortho-Clinical Diagnostics | VITROS DAT Performance Verifier | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161474 |
| mdprc 045 03 18 000 | Stryker Sustainability Solutions | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161322 |
| mdprc 044 03 18 000 | Wiener Laboratories | Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161541 |
| mdprc 032 03 18 000 | DePuy International Ltd | Concorde Lift | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161277 |
| mdprc 031 03 18 000 | Stryker Communications | StrykeFlow 2 suction/irrigator, STRYKER WEDGE, ACL DISPOSABLE , STRYKER CASSETTE PUMP | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160091 |
| mdprc 030 03 18 000 | Toshiba | Fluoroscopic XRay Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161847 |
| mdprc 028 03 18 000 | Accord Media, LLC | Ultra Renew, Truth Renew, Ultra Renew Plus, Truth Renew Plus | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161783 |
| mdprc 027 03 18 000 | Alto Development Corp | MYO/Punch; A&E Surgical Punch | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161805 |
| mdprc 026 03 18 000 | Baxter Healthcare | Sterile EXACTAMED Oral Liquid Dispenser | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161319 |
| mdprc 025 03 18 000 | Hitachi America, Ltd. | UST5550R Ultrasound Transducer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161462 |
| mdprc 024 03 18 000 | Howmedica Osteonics Corp. | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161444 |
| mdprc 023 03 18 000 | NxStage Medical, Inc. | Dialysate Sacks | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161554 |
| mdprc 022 03 18 000 | Otto Bock Healthcare Products GmbH | OTTO BOCK Kenevo knee joints | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161206 |
| mdprc 017 03 18 000 | Avid Medical, Inc. | AVID TruCustom | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161497 |
| mdprc 016 03 18 000 | B Braun Medical Inc | Sterile IV Start Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149990 |
| mdprc 010 03 18 000 | Cosmedent, Inc. | Dentin/Enamel Etch | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159642 |
| mdprc 009 03 18 000 | Keystone Dental Inc. | RESTORE, STAGE1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161389 |
| mdprc 008 03 18 000 | Keystone Dental Inc. | Max Implant System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161267 |
| mdprc 007 03 18 000 | Medistim ASA | VeriQ System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160991 |
| mdprc 006 03 18 000 | Steris Corporation | Sterilization Wrap | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161343 |
| mdprc 005 03 18 000 | Terumo BCT Inc | Destination Guiding Sheath | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161503 |
| mdprc 130 02 18 000 | Arrow International Inc | ARROW PICC | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161626 |
| mdprc 129 02 18 000 | Atrium Medical Corporation | ProLite Mesh | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161830 |
| mdprc 128 02 18 000 | DePuy International Limited | FMS Gravity Tube Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161398 |
| mdprc 127 02 18 000 | Siemens Medical Solutions | Artis Q and Q.Zen, Artis Zee and Zeego, Axiom Artis | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161336 |
| mdprc 126 02 18 000 | Med Tec Inc | Protura Software which utilizes Elektas iCOM interface | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161544 |
| mdprc 125 02 18 000 | Zimmer, INC | NexGen LPS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160970 |
| mdprc 117 02 18 000 | Medtronic SA | Implantable Cardioverter Defibrillators (ICDs) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161074 |
| mdprc 101 02 18 000 | DeRoyal Industries Inc. | GEOMED CABG PACK PGYBK A & B | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161247 |
| mdprc 100 02 18 000 | Zimmer, INC | ROSA 1.0.2, ROSA 3.0 (Spine application) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160940 |
| mdprc 096 02 18 000 | Aesculap | ELAN 4 Air System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161326 |
| mdprc 095 02 18 000 | Aesculap | ELAN 4 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161269 |
| mdprc 094 02 18 000 | Aesculap | Sterilization wrap, JS Series SterilContainer"S2 System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161320 |
| mdprc 093 02 18 000 | Cook Inc, | Central Venous Catheter. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161240 |
| mdprc 092 02 18 000 | Fukuda Denshi | Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159575 |
| mdprc 091 02 18 000 | Zimmer Biomet | AGC Porous Patellar SM and Med | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161330 |
| mdprc 090 02 18 000 | Zimmer Biomet | Acetabular Hip Replacement Components | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161382 |
| mdprc 084 02 18 000 | Gibson Laboratories LLC | Gibson Bioscience Blastomyces dermatitidis Antiserum | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160239 |
| mdprc 083 02 18 000 | Keystone Dental Inc. | PrimaConnex Implant System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161223 |
| mdprc 082 02 18 000 | OrthoPediatrics Corp | thoracolumbosacral pedicle screw system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161268 |
| mdprc 081 02 18 000 | PENTAX Europe GmbH | Video Cystoscope models ECY1570 and ECY1570K | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161420 |
| mdprc 080 02 18 000 | Sanofi Genzyme | SynviscOne | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160495 |
| mdprc 060 02 18 000 | Beckman Coulter | AU Lyophilized Chemistry Level 1 Calibrators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160143 |
| mdprc 059 02 18 000 | ConforMIS | iTotal Posterior Stabilized (PS) Knee Replacement System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160828 |
| mdprc 058 02 18 000 | Exactech | Exactech GPS Total Shoulder Application 3.2mm Vix Bit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158599 |
| mdprc 057 02 18 000 | Synthes Inc | Titanium Trochanteric Fixation Nail (TFN) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160966 |
| mdprc 056 02 18 000 | Cepheid | Xpert CT/NG. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160839 |
| mdprc 055 02 18 000 | HOLOGIC NV | Hologic Panther(R) Fusion | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161072 |
| mdprc 044 02 18 000 | Avid Medical, Inc. | AVID Medical QA Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161426 |
| mdprc 043 02 18 000 | B Braun Medical Inc | Spinal & Epidural Anesthesia Tray | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160795 |
| mdprc 042 02 18 000 | Cyberonics Inc | VNS(R) Therapy Programmer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160846 |
| mdprc 041 02 18 000 | LITTLE RAPIDS CORPORATION | SnugFit(R) Expandable Mattress Cover | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160825 |
| mdprc 040 02 18 000 | Medtronic SA | Medtronic ANGLED DRILL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160709 |
| mdprc 039 02 18 000 | Mindray DS USA, Inc., dba Datascope Patient Monitoring | TD60 Transmitter Battery Charger | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161211 |
| mdprc 038 02 18 000 | Philips Healthcare | HeartStart MRx Monitor/Defibrillator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159291 |
| mdprc 037 02 18 000 | Smiths Medical | Custom Made Tracheostomy Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161230 |
| mdprc 036 02 18 000 | 3M Health Care Ltd | ACE(TM) BRAND, ULTRA LITE ANKLE brace | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159601 |
| mdprc 035 02 18 000 | Robert Busse & Co. Inc | Lumbar Puncture Tray | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160967 |
| mdprc 034 02 18 000 | Zimmer Biomet | Zimmer Natural Nail System Tear Drop Guide Wire | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158903 |
| mdprc 030 02 18 000 | Implant Direct Sybron Manufacturing,LLC | Implant Direct, INTERACTIVE HEALING COLLAR | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160855 |
| mdprc 029 02 18 000 | Medical Components, Inc | Plastic Dignity Low Profile CT Port | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158909 |
| mdprc 025 02 18 000 | ConvaTec | SURFIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159675 |
| mdprc 024 02 18 000 | Siemens Medical Solutions | Syngo.plaza systems. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160104 |
| mdprc 023 02 18 000 | Spacelabs Healthcare Inc | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161031 |
| mdprc 022 02 18 000 | Panoramic Rental Corp. | Panoramic Xray Model PC1000, Laser1000 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158982 |
| mdprc 010 02 18 000 | Siemens Medical Solutions | Syngo.plaza Picture Archiving and Communication System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161248 |
| mdprc 009 02 18 000 | Tosoh Corporation | Tosoh Automated Enzyme Immunoassay Analyzer AIA900, Tosoh Sorter 9tray and Tosoh Sorter 19tray | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160396 |
| mdprc 004 02 18 000 | Alere | Triage Drugs of Abuse Plus TCA 25 Test Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159878 |
| mdprc 003 02 18 000 | C R Bard Inc | UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158971 |
| mdprc 002 02 18 000 | Exactech | Equinoxe Cage, Glenoid, Alpha, Small and Medium | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160830 |
| mdprc 097 01 18 000 | Carl Zeiss Meditec Inc | Metrotom 800 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160805 |
| mdprc 096 01 18 000 | SOMATEX Medical Technologies GmbH | Tumark Q | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159289 |
| mdprc 094 01 18 000 | Inovo, Inc | Pure Stationary Oxygen Concentrators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160803 |
| mdprc 093 01 18 000 | Siemens Medical Solutions | Syngo Imaging | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160841 |
| mdprc 092 01 18 000 | Smith & Nephew inc | EVOS FLEX PLATE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160095 |
| mdprc 091 01 18 000 | Smith & Nephew inc | Radial Osteotome Blade | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159544 |
| mdprc 090 01 18 000 | Vyaire Medical | AirLife Humidification Chambers and Heated Breathing Circuits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160041 |
| mdprc 078 01 18 000 | Valeant Pharmaceuticals International, Inc | SPAG2 unit nebulizers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155627 |
| mdprc 074 01 18 000 | Measurement Specialties Inc. | Measurement Specialties Reusable Temperature Probe Autoclavable | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158538 |
| mdprc 073 01 18 000 | Philips Healthcare | Brilliance iCT, Brilliance 64, Ingenuity Core, and Ingenuity Core128 Computed Tomography Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160870 |
| mdprc 072 01 18 000 | Smith & Nephew inc | MiniMod Small Bone Plating System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160614 |
| mdprc 071 01 18 000 | The Anspach Effort, Inc | OSCILLATING SAW ATTACHMENT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160829 |
| mdprc 062 01 18 000 | ZOLL Medical Corp | LifeVest Wearable Defibrillator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160876 |
| mdprc 060 01 18 000 | Merge Healthcare Corp. | Mighty 8 Power strip, TrippLite Power strip | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154394 |
| mdprc 058 01 18 000 | DeRoyal Industries Inc. | DeRoyal Sterile Custom kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160713 |
| mdprc 052 01 18 000 | Physio Control Inc | LIFEPAK 20e Defibrillator/Monitors | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159792 |
| mdprc 051 01 18 000 | SPINEART | TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160051 |
| mdprc 046 01 18 000 | Amendia, Inc | Mac Pin NonCannulated Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158459 |
| mdprc 045 01 18 000 | Encore Medical, Lp | EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, MEDIUM and SMALL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160234 |
| mdprc 044 01 18 000 | OrthoScan, Inc. | OrthoScan Mobile DI Mini Carm, OrthoScan Mobile DI Mini Carm, HD (10000001), HD (10000004) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160429 |
| mdprc 037 01 18 000 | Amendia, Inc | Ceres SelfDrilling Variable Screw 4.0 x 12mm | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158455 |
| mdprc 036 01 18 000 | King Systems Corp. dba Ambu, Inc. | UNIVERSAL FLEX2 BREATHING CIRCUIT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160526 |
| mdprc 035 01 18 000 | ProSun International, LLC | Sundream 12 V tanning bed | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159784 |
| mdprc 034 01 18 000 | Repro-Med Systems, Inc | Freedom 60 Precision Flow Rate Tubing Sets | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153551 |
| mdprc 033 01 18 000 | Zimmer Biomet, Inc. | RingLoc Acetabular Shells | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160291 |
| mdprc 019 01 18 000 | Smiths Medical ASD Inc | CADD Legacy | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160096 |
| mdprc 002 01 18 000 | St. Jude Medical Inc | Agilis | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156097 |
| mdprc 001 01 18 000 | Zimmer inc | OSS CEMENTED IM STEM , CER BIOLOXD OPTION HD , CER OPTION TYPE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158814 |
| mdprc 119 12 17 000 | Accuray Inc | TomoHDA System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160116 |
| mdprc 103 12 17 000 | L3 Security & Detection | Examiner 3DX 6000 StandAlone & InLine Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160074 |
| mdprc 102 12 17 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products PHYT Slides | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156825 |
| mdprc 101 12 17 000 | Randox Laboratories Ltd. | HbA1c | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156814 |
| mdprc 100 12 17 000 | Stryker Neurovascular | Stroke Fast Pack. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159875 |
| mdprc 099 12 17 000 | Stryker Sustainability Solutions | VenaFlow Calf Garment (Aircast) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160214 |
| mdprc 081 12 17 000 | C R Bard Inc | ArcticGel Pads | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160082 |
| mdprc 080 12 17 000 | C R Bard Inc | I125 CE Marked QuickLink Cartridges | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156058 |
| mdprc 079 12 17 000 | NXTHERA | Rezum System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157922 |
| mdprc 064 12 17 000 | AngioDynamics Inc | BioStable 5F DL55CM MST70 KIT NonValved w/ Nit GW | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160033 |
| mdprc 063 12 17 000 | ConMed Corporation | PopLok Knotless Suture Anchor with Disposable Driver | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154857 |
| mdprc 062 12 17 000 | Ortho-Clinical Diagnostics | enGen Laboratory Automation System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155157 |
| mdprc 056 12 17 000 | Amendia, Inc | Omni Spine Anterior Cervical Plate System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159848 |
| mdprc 055 12 17 000 | DUKAL | Dukal Burn Sheets | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159183 |
| mdprc 054 12 17 000 | FUJIFILM Medical Systems | FDR Visionary Suite with CH200 stationary xray system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160059 |
| mdprc 041 12 17 000 | Biosense Webster Inc. | SMARTABLATE System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156581 |
| mdprc 040 12 17 000 | United Nuclear Scientific Supplies, LLC | High Power Handheld Laser | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159398 |
| mdprc 026 12 17 000 | DeRoyal Industries Inc. | DeRoyal Sterile Custom kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159686 |
| mdprc 025 12 17 000 | Exactech | Vintage Total Ankle Tibia Insert | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156247 |
| mdprc 024 12 17 000 | Won Industry Co. | Morning Life | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158850 |
| mdprc 012 12 17 000 | VOLCANO CORPORATION | Volcano s5i, CORE and CORE Mobile systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159781 |
| mdprc 003 12 17 000 | Implant Direct Sybron Manufacturing,LLC | Legacy 3 Implant | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159290 |
| mdprc 002 12 17 000 | Medtronic Inc | Everflex SelfExpanding Peripheral Stent with Entrust Delivery System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159783 |
| mdprc 125 11 17 000 | Brainlab AG | BRAINLAB EXACTRAC VERO | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159653 |
| mdprc 124 11 17 000 | Zimmer Biomet | Computer Assisted Surgical Device. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157472 |
| mdprc 123 11 17 000 | Zimmer Biomet | ComputerAssisted Surgical Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159343 |
| mdprc 122 11 17 000 | Zimmer Biomet | ROSA Spine 1.0.2 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159599 |
| mdprc 094 11 17 000 | Medline Industries Inc | Transfer/Gait Belt | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159345 |
| mdprc 093 11 17 000 | Becton Dickinson & Co. (BD) | BD Phoenix PMIC107 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155855 |
| mdprc 092 11 17 000 | Zimmer Biomet | ComputerAssisted Surgical Device. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157814 |
| mdprc 091 11 17 000 | Zimmer Biomet | ComputerAssisted Surgical Device.. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159350 |
| mdprc 090 11 17 000 | Siemens Medical Solutions | Syngo.plaza | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156080 |
| mdprc 089 11 17 000 | Resource Optimization & Innovation Llc | Regard Custom Surgical Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159384 |
| mdprc 088 11 17 000 | Medline Industries Inc…. | Green Polyisoprene Surgical Gloves with Aloe Vera | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159624 |
| mdprc 081 11 17 000 | Abbott | CELL-DYN Ruby | NCMDR |
| mdprc 080 11 17 000 | Zimmer Biomet | ComputerAssisted Surgical Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157798 |
| mdprc 079 11 17 000 | Zimmer Biomet | ComputerAssisted Surgical Device, ROSA BRAIN 3.0.0 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157797 |
| mdprc 078 11 17 000 | Terumo BCT Inc | HARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159143 |
| mdprc 077 11 17 000 | Smith & Nephew inc | LEGION LWEDGE. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158754 |
| mdprc 076 11 17 000 | Medline Industries Inc…. | MEDLINE PEDI ELBOW and COUBLE SWIVEL CLOSED SUCTION CATHETER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159165 |
| mdprc 075 11 17 000 | ICU Medical, Inc | ICU Medical Intravenous Sets with Stopcocks | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158863 |
| mdprc 074 11 17 000 | Smith & Nephew inc | LEGION LWEDGE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158754 |
| mdprc 073 11 17 000 | Smith & Nephew inc | TRIGEN INTERTAN 10S | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159397 |
| mdprc 072 11 17 000 | Siemens Medical Solutions | Symbia Intevo 6 and 16 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158854 |
| mdprc 071 11 17 000 | Arthrex Inc | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159082 |
| mdprc 049 11 17 000 | Smiths Medical ASD Inc.. | CADD Medication Cassette Reservoir | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159024 |
| mdprc 048 11 17 000 | WalkMed Infusion, LLC | Reservoir Bag for Infusion Pump | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159086 |
| mdprc 037 11 17 000 | Zimmer inc | Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159084 |
| mdprc 036 11 17 000 | Windstone Medical Packaging, Inc | T&A Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159349 |
| mdprc 035 11 17 000 | Terumo BCT Inc | Harvest Graft Delivery GDP-10 Procedure Packs , | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159146 |
| mdprc 034 11 17 000 | Sorin Group | FlexFlowTM venous cannula Catalog 200200 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159209 |
| mdprc 033 11 17 000 | Northgate | 9195371DS Lithrotripsy Probe LotLDS12516 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155847 |
| mdprc 032 11 17 000 | North Star Imaging Inc | Xray Cabinet Models | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159021 |
| mdprc 031 11 17 000 | Invivo Corporation | Flex Cardio Patient Monitoring System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159623 |
| mdprc 030 11 17 000 | Epimed International Inc | Tuohy Epidural Needles | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158023 |
| mdprc 029 11 17 000 | Encore Medical, Lp | Cobalt HV Bone Cement.. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158794 |
| mdprc 028 11 17 000 | Bioseal Corporation | Custom surgical kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159381 |
| mdprc 027 11 17 000 | Aaren Scientific Inc, | Z28 Cartridges | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158541 |
| mdprc 012 11 17 000 | Teleflex Medical | Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Gripper Grasper | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159243 |
| mdprc 108 10 17 000 | Alcon Laboratories Inc. | Alcon Surgical Procedure Packs | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158368 |
| mdprc 107 10 17 000 | Bios S.r.l. | THERMI250 Radiofrequency System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157831 |
| mdprc 106 10 17 000 | EDAP TMS FRANCE SAS | Ablatherm Integrated Imaging device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158643 |
| mdprc 100 10 17 000 | Beckman Coulter | Power Processor 1K Stockyard | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158433 |
| mdprc 087 10 17 000 | Kamiya Biomedical Company, LLC | KAssay(R) MultiAnalyte Calibrator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158212 |
| mdprc 086 10 17 000 | Hologic Inc | Panther(R) System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158900 |
| mdprc 085 10 17 000 | Genesys Orthopedic Systems | Genesys spine, Binary Screwdriver | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158848 |
| mdprc 084 10 17 000 | Encore Medical, Lp | EMPOWR PS KNEE(TM) e | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158867 |
| mdprc 065 10 17 000 | Toshiba Medical Systems Corporation | Kalare (DREXKL80) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158813 |
| mdprc 052 10 17 000 | Handicare Ltd | Carina Mobile Lifts | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158744 |
| mdprc 034 04 17 001 | bioMerieux Inc | NucliSENS Lysis Buffer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153791 |
| mdprc 044 10 17 000 | Handicare Ltd | PRISM MEDICAL A625 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158653 |
| mdprc 030 10 17 000 | Philips Healthcare | IntelliVue Information Centers, Monitors | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156055 |
| mdprc 018 10 17 000 | Implant Direct LLC | Swish DuoGrip Healing Collar | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157875 |
| mdprc 010 10 17 000 | BOMImed Inc | BOMImed Disposable Fiber Optic Medium Laryngoscope Handle | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158329 |
| mdprc 009 10 17 000 | Medtronic SA | Heli-FX Guide Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158729 |
| mdprc 008 10 17 000 | Novadaq Technologies Inc. | SPY-PHI Drapes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158170 |
| mdprc 007 10 17 000 | Radiometer America Inc | AutoCheck5 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158651 |
| mdprc 006 10 17 000 | The Metrix Co | SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158688 |
| mdprc 005 10 17 000 | Deerfield Imaging | Head Fixation Device (HFD100) Starburst adaptor thumb screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158467 |
| mdprc 004 10 17 000 | Firefly Medical, Inc | IVEA | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158512 |
| mdprc 003 10 17 000 | Teleflex Medical | LMA(TM) MADgic(TM) LaryngoTracheal Mucosal Atomization Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158408 |
| mdprc 002 10 17 000 | Zimmer Biomet | Drill Bit QuickConnect | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156023 |
| mdprc 001 10 17 000 | Zimmer Biomet | Endosseous Dental Implant Accessories | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158315 |
| mdprc 050 09 17 000 | FUJIFILM Corporation | Various Duodenoscopes ,. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154542 |
| mdprc 049 09 17 000 | Baxter Corp Canada | Baxter Amia Automated Peritoneal Dialysis Set with Cassette | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158638 |
| mdprc 048 09 17 000 | Becton Dickinson & Co. (BD) | BD Needle 22GA 11/2in SafetyGlide | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157172 |
| mdprc 047 09 17 000 | Boston Scientific | FFR LinkFFR Signal Processing Module | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156068 |
| mdprc 046 09 17 000 | X-Laser Llc | Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 models | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158026 |
| mdprc 045 09 17 000 | Zimmer Biomet | Herga foot switch, a component of ROSA Surgical Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156850 |
| mdprc 044 09 17 000 | Orthofix | Firebird NXG Spinal Fixation System Decorticating Planer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158127 |
| mdprc 034 09 17 000 | Organ Recovery Systems | SPS-1 Static Preservation Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151877 |
| mdprc 029 09 17 000 | Toshiba Medical Systems Corporation | Ultimax Digital Fluoroscopic XRay System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157489 |
| mdprc 028 09 17 000 | Merge Healthcare Corp. | Merge Unity software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157956 |
| mdprc 007 09 17 000 | Encore Medical, Lp | Turon Glenoid Reamer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158249 |
| mdprc 006 09 17 000 | Beckman Coulter | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis Systems. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157861 |
| mdprc 003 09 17 000 | Vyaire Medical | AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158028 |
| mdprc 002 09 17 000 | Neusoft Medical System Co. | NeuViz 64 Multislice CT Scanner System, NeuViz 128 CT Scanner System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156762 |
| mdprc 001 09 17 000 | Master & Frank Enterprise Co Ltd | MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156974 |
| mdprc 106 08 17 000 | Certified Safety Mfg Inc. | Burn Sheet, sterile 60 x 96 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156722 |
| mdprc 098 08 17 000 | Smiths Medical ASD Inc. | CADD(R) Medication Cassette with clamp and female Luer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156494 |
| mdprc 097 08 17 000 | Medspira LLC | mcompass Balloon 2-Channel Catheters | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157691 |
| mdprc 096 08 17 000 | Kentec Medical Inc | ENFit(R) AMERITUS NG FEEDING TUBE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157812 |
| mdprc 095 08 17 000 | bioMerieux Inc | VITEK 2 Compact 15 and VITEK 2 Compact 30 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157918 |
| mdprc 087 08 17 000 | Acumed LLC | OPT Croutons synthetic bone substitute | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151650 |
| mdprc 085 08 17 000 | Solta Medical | VASER Amplifiers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157186 |
| mdprc 084 08 17 000 | Custom Assemblies Inc | Various custom surgical kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158352 |
| mdprc 083 08 17 000 | Cardinal Health.. | Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158213 |
| mdprc 082 08 17 000 | Alcon Research, Ltd | ORA System with VerifEye | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157981 |
| mdprc 065 08 17 000 | Randox Laboratories Ltd. | IgE Calibrator Series | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149667 |
| mdprc 064 08 17 000 | Boston Scientific Ltd | Various S-ICD Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157929 |
| mdprc 044 08 17 000 | Cenorin | ThermaSure, a CENORIN product, 1000 Series, 130 Series, 300 Series | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157002 |
| mdprc 029 08 17 000 | Exactech | Manual Surgical Instrument | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156716 |
| mdprc 028 08 17 000 | Valorem Surgical LLC | MAXIMIS Pedicle Screw Spinal Fixation System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156169 |
| mdprc 027 08 17 000 | Sorin Group | Cardiopulmonary Bypass Catheter Cannula and Tubing | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157559 |
| mdprc 026 08 17 000 | GE Healthcare | SIGNA, Brivo, Optima MRI | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156163 |
| mdprc 025 08 17 000 | C R Bard Inc | leg bag | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157782 |
| mdprc 024 08 17 000 | Stryker | Stroke Fast Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157439 |
| mdprc 023 08 17 000 | Spectranetics Corporation | Rapid Exchange Turbo Elite Atherectomy Catheters | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156104 |
| mdprc 021 08 17 000 | Myelotec Inc. | 2010 Video Guided Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156176 |
| mdprc 118 07 17 000 | Smiths Medical ASD Inc.. | CADD BlueStriped Administration Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157885 |
| mdprc 117 07 17 000 | Fisher Diagnostics | Pacific Hemostasis Fibrinogen Degradation Products | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155789 |
| mdprc 116 07 17 000 | Cardinal Health.. | Converters(R) Tiburon(R) Arthroscopy Drape | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157506 |
| mdprc 109 07 17 000 | GE Medical Systems | OEC 9800 and OEC 9900 Elite | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152098 |
| mdprc 108 07 17 000 | Penumbra, Inc. | 3D Revascularization Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156554 |
| mdprc 107 07 17 000 | PENTAX Medical | Cart-Mounted Computer Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155016 |
| mdprc 106 07 17 000 | Medtronic SA | Spine Tools Install CDs Used with StealthStation S7 Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155812 |
| mdprc 105 07 17 000 | Medtronic SA | Visualase Cooled Laser Applicator System 15 mm Tip Caps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156887 |
| mdprc 093 07 17 000 | Mesa Laboratories, Inc. | Conductivity/TDS Calibrator Solution. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155840 |
| mdprc 092 07 17 000 | Flowonix Medical | Prometra II Programmable Pumps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156065 |
| mdprc 070 07 17 000 | Beckman Coulter UK Ltd | Synchron Systems AQUA Cal 1 Reagents | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155844 |
| mdprc 069 07 17 000 | ICU Medical, Inc | Stopcock, i.V. Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156514 |
| mdprc 068 07 17 000 | Merge Healthcare Corp. | Schiller PB 1000 Used with Hemo Software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154942 |
| mdprc 067 07 17 000 | Natus Neurology | Elite 2,Elite 3,Elite 5 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156547 |
| mdprc 066 07 17 000 | Oscor Inc. | Reusable ATAR Extension Cables | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154469 |
| mdprc 065 07 17 000 | O-Two Medical Technologies, Inc | Timer, General Laboratory | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156310 |
| mdprc 064 07 17 000 | PENTAX Europe GmbH | Pentax Video Duodenoscope | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155670 |
| mdprc 048 07 17 000 | Arrow International Inc | Arrow Glide Thru PeelAway Sheath/Dilator Introducer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156760 |
| mdprc 047 07 17 000 | BD Biosciences | Model 8100 Alaris Pump Modules and Pump Module Door Latch Kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155608 |
| mdprc 046 07 17 000 | Exactech | Tibial Augment Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156193 |
| mdprc 045 07 17 000 | Ion Beam Applications S.A. | ProteusPlus, Proteus 235, Proton Therapy System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156863 |
| mdprc 044 07 17 000 | Mallinckrodt AG | Tenaxis Medical ArterX(TM) Surgical Sealant | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156110 |
| mdprc 043 07 17 000 | Natus Medical Inc. | Olympic Pasteurmatic 3000; Olympic Pasteurmatic 3500 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153196 |
| mdprc 037 07 17 000 | SIEMENS | Vibe Sensis Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155711 |
| mdprc 017 07 17 000 | Ion Beam Applications S.A. | Proteus 235 and Proteus ONE proton therapy systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156859 |
| mdprc 016 07 17 000 | AGFA Corp. | IMPAX Cardiovascular | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156955 |
| mdprc 015 07 17 000 | bioMerieux Inc. | VIDAS Testosterone | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155630 |
| mdprc 014 07 17 000 | JAS Diagnostics Inc. | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156089 |
| mdprc 013 07 17 000 | 3M Health Care Ltd | 3M Ranger(TM) Pressure Infusor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155950 |
| mdprc 012 07 17 000 | Boston Scientific Ltd | Imager II Angiographic Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154140 |
| mdprc 011 07 17 000 | CryoLife, Inc. | BioGlue Surgical Adhesive | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155852 |
| mdprc 010 07 17 000 | Mindray DS USA, Inc. | TI Transport Monitor/Module Battery Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155916 |
| mdprc 009 07 17 000 | Onkos Surgical, Inc. | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156329
|
| mdprc 083 06 17 000 | Depuy Orthopaedics, Inc. | LATARJET EXPERIENCE Systems Instruments | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155555
|
| mdprc 082 06 17 000 | IBA Dosimetry GmbH | Proteus 235 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155167 |
| mdprc 081 06 17 000 | Merge Healthcare Corp. | Merge PACS software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155551 |
| mdprc 080 06 17 000 | Merge Healthcare Corp. | Merge PACS software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155552 |
| mdprc 079 06 17 000 | Omega Medical Imaging, Inc. | 2 over 2 Elevating Monitor Suspension pillar/column accessory | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156081 |
| mdprc 078 06 17 000 | SIEMENS | SOMATOM Perspective, SOMATOM Scope Power, and SOMATOM Scope | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151463
|
| mdprc 077 06 17 000 | Teleflex Medical | Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155751 |
| mdprc 076 06 17 000 | Z-Medica LLC | QuikClot TraumaPads | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155692 |
| mdprc 059 06 17 000 | Monica Healthcare Ltd. | Uterine Electromyographic Monitor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155680 |
| mdprc 058 06 17 000 | Teleflex Medical.. | Various Arrow Arterial, CVC, Hemodialysis, MAC, PICC, and PSI Kits , | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155537 |
| mdprc 057 06 17 000 | GE Healthcare | Various CT, NM, and PET Scanners | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155861 |
| mdprc 056 06 17 000 | Arrow International Inc | ARROWgard Blue CVC, ARROW MAC TwoLumen Central Venous Access, Arrow Pressure Injectable PICC Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155539 |
| mdprc 047 06 17 000 | OrthoPediatrics Corp | Response BandLoc 5.5/6.0 Tensioner Instrument | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155589 |
| mdprc 045 06 17 000 | Nexstim OY | Nexstim, NBS System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155420 |
| mdprc 041 06 17 000 | GE Healthcare | Infant Radiant Warmer. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155625 |
| mdprc 040 06 17 000 | Depuy Orthopaedics, Inc | DePuy Synthes orthopedic instruments | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151963 |
| mdprc 027 06 17 000 | Magellan Diagnostics Inc | LeadCare Blood Lead Testing Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155438 |
| mdprc 026 06 17 000 | Laserex Systems Inc | Tango Reflex | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155147 |
| mdprc 025 06 17 000 | Circadiance LLC | SmartMonitor 2 PS/PSL Monitors | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155172 |
| mdprc 024 06 17 000 | Argon Medical Devices | Clear Flashback and Winged Arterial Needles | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155591 |
| mdprc 023 06 17 000 | Stryker Communications | Berchtold Chromophare | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155570 |
| mdprc 017 06 17 000 | Orthosoft, Inc | Sesamoid Plasty | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154865 |
| mdprc 016 06 17 000 | Madison Polymeric Engineering | Draco Enzymatic DeepCleaning Pad with Enzymatic Detergent | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155123 |
| mdprc 015 06 17 000 | Cell Marque Corporation | Estrogen Receptor (EP1) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155439 |
| mdprc 014 06 17 000 | Cardinal Scale Mfg Co | Cardinal, Digital Bariatric Scale | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154739 |
| mdprc 013 06 17 000 | Baxter | Transfer Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153044 |
| mdprc 005 06 17 000 | Vascular Solutions Inc | dolphin Inflation Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154966 |
| mdprc 004 06 17 000 | Toshiba American Medical Systems Inc | Toshiba Angio WorkStation (XIDFAWS801) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155327 |
| mdprc 003 06 17 000 | Hans Pausch Rontgengeratebau Gmbh | Pausch Medical Uroview FD | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154240 |
| mdprc 002 06 17 000 | Acumed LLC | Acumed SlideLoc Anatomic Radial Head System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154986 |
| mdprc 001 06 17 000 | AbbVie Inc.. | AbbVie PEG, PEG Kit 15FR, 20FR | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155421 |
| mdprc 148 05 17 000 | Zimmer Biomet | SpFXL IIB 2/DM and SpFPLUS Implantable Stimulators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154946 |
| mdprc 147 05 17 000 | Medtest Holdings, Inc | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154879 |
| mdprc 146 05 17 000 | CORPAK MedSystems . | CORFLO PEG Y Adapters with ENFit Connectors | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155499 |
| mdprc 145 05 17 000 | Arrow International Inc. | Arrow VPS Access Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155122 |
| mdprc 142 05 17 000 | Cardiovascular Systems, Inc | Saline Infusion Pumps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154675 |
| mdprc 138 05 17 000 | Implant Direct LLC | HLA3-5 Legacy Full Contour Abutment Assemblies | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155149 |
| mdprc 137 05 17 000 | Cardiovascular Systems, Inc | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154675 |
| mdprc 136 05 17 000 | Bard Pcripheral Vascular (BPV) | StatLock IV Premium Catheter Stabilization Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155010 |
| mdprc 135 05 17 000 | B Braun Medical Inc | Elcam CytoGuard Closed Luer Connectors | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155027 |
| mdprc 134 05 17 000 | Mesa Laboratories, Inc. | Conductivity/TDS Calibrator Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155628 |
| mdprc 133 05 17 000 | Bard Pcripheral Vascular (BPV) | StatLock IV Premium Catheter Stabilization Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155010 |
| mdprc 132 05 17 000 | Cardiovascular Systems, Inc | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154675 |
| mdprc 131 05 17 000 | Implant Direct LLC | HLA3-5 Legacy Full Contour Abutment Assemblies | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155149 |
| mdprc 127 05 17 000 | bioMerieux Inc | ETEST Ceftriaxone | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155036 |
| mdprc 126 05 17 000 | Cardiovascular Systems, Inc. | Saline Infusion Pumps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154675 |
| mdprc 125 05 17 000 | Magellan Diagnostics Inc. | Magellan Diagnostics LeadCare Ultra Blood Analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154783
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154782 |
| mdprc 124 05 17 000 | Zimmer inc. | NexGen Offset Stem Extension | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155137 |
| mdprc 113 05 17 000 | Medline Industries Inc | Anterior Cervical Distraction Pins | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152774 |
| mdprc 112 05 17 000 | Ziehm Imaging GmbH. | Ziehm Solo FD | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154847 |
| mdprc 088 05 17 000 | Del Mar Reynolds Medical | Arkon Anesthesia Delivery System. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154830 |
| mdprc 087 05 17 000 | IBA Dosimetry GmbH | Proteus One, Proteus Plus | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154743 |
| mdprc 076 05 17 000 | Vortran Medical Technology 1, Inc | VORTRAN Automatic Resuscitator, VARPlus | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154926 |
| mdprc 075 05 17 000 | Stryker Instruments | Stryker PROFESS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154817 |
| mdprc 074 05 17 000 | Orthosoft, Inc | Navitrack System OS Knee Universal, Stereotaxic instrument | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154873 |
| mdprc 073 05 17 000 | Ortho-Clinical Diagnostics | enGen Laboratory Automation Systems Using TCAutomation Software with InOut Communication Interface | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154093 |
| mdprc 072 05 17 000 | Mentor Texas Inc | SalineFilled SPECTRUM Breast Implants | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154428 |
| mdprc 071 05 17 000 | Hitachi Medical Corp | Arietta70 Ultrasound System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154883 |
| mdprc 070 05 17 000 | Eden Medical | GIZA Vertebral Body Replacement | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154405 |
| mdprc 069 05 17 000 | Biomet Microfixation | Biomet Microfixation TraumaOne System Surgical Tray | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154834 |
| mdprc 068 05 17 000 | Zimmer Biomet | Regenerex Series A Patella Pegs . | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154964 |
| mdprc 067 05 17 000 | Stryker Communications | Gaymar Medi-Therm Hypothermia Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154824 |
| mdprc 066 05 17 000 | Almore International Inc | Microfil Composite Instruments | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154721 |
| mdprc 057 05 17 000 | Med-Hot Thermal Imaging, Inc | MEDHOT MTI 2000 THERMAL IMAGING SYSTEMMed | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153694 |
| mdprc 056 05 17 000 | GREATBATCH MEDICAL | Linear Straight Broach Handle, (Rasp Handle) EZ Clean" Linear Broach Handle | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154992 |
| mdprc 055 05 17 000 | The Anspach Effort, Inc. | Table and attachments, operating-room | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152393 |
| mdprc 054 05 17 000 | Orthosoft, Inc | NDI P7 Position Sensor, Stereotaxic Instrument | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154878 |
| mdprc 053 05 17 000 | Medtronic Sofamor Danek | PAK NEEDLE BEVELED AND TROCAR TIPS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154880 |
| mdprc 052 05 17 000 | Mederi Therapeutics, Inc | Mederi Stretta Catheter and Accessory Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154736 |
| mdprc 042 05 17 000 | Sysmex America Inc | Sysmex XN Series Automated Hematology Analyzers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154358 |
| mdprc 041 05 17 000 | Smith & Nephew inc | PERILOC VOLAR DISTAL RADIUS RIGHT 3H STD HEAD LOCKING PLATE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154604 |
| mdprc 040 05 17 000 | Dale Medical Products, Inc. | Dale Medical Stabilock Endotracheal Tube Holder, Adhesive Base | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154789 |
| mdprc 039 05 17 000 | C R Bard Inc | GHIATAS Beaded Breast Localization Wires | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154553 |
| mdprc 038 05 17 000 | Breg Inc | Various Dressings | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154790 |
| mdprc 037 05 17 000 | Boston Scientific. | JETSTREAM | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154677 |
| mdprc 033 05 17 000 | XTANT MEDICAL INC | Fortex Pedicle Screw System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154382 |
| mdprc 032 05 17 000 | Ulrich GmbH & Co. KG | uNion CPS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154069 |
| mdprc 030 05 17 000 | Sonesta Medical | Sonesta S2 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154929 |
| mdprc 029 05 17 000 | Savaria Concord Lifts, Inc. | Omega Incline Platform Lift. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154907 |
| mdprc 028 05 17 000 | Richard-Allan Scientific | Shandon Rapid Chrome KwikDiff | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154823 |
| mdprc 027 05 17 000 | Remel | Blood Agar (TSA with 5 Sheep Blood) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154393 |
| mdprc 026 05 17 000 | Orthosoft, Inc | Navitrack System OS Knee Universal | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154874 |
| mdprc 024 05 17 000 | Medtronic SA | HeartWare Ventricular Assist Device Controllers and Heart Ware 1435 DC Adapters | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153628 |
| mdprc 023 05 17 000 | Amendia, Inc | Guide Wires | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154922 |
| mdprc 013 05 17 000 | Ion Beam Applications S.A. | Proteus Plus | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154230 |
| mdprc 012 05 17 000 | Philips Burton | BrightView SPECT, XCT, X 3/4 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154006 |
| mdprc 056 04 17 001 | Cardiovascular Systems, Inc | ViperWire Advance Peripheral Guide Wire with Flex Tip | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154580 |
| mdprc 011 05 17 000 | Zimmer Biomet | SmartTools Knee System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153399 |
| mdprc 010 05 17 000 | BD Diagnostic Systems | BD Viper LT software, version 3.00H | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154526 |
| mdprc 009 05 17 000 | Avid Medical, Inc. | Vacutainer Tubes | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154076 |
| mdprc 008 05 17 000 | Arrow International Inc | Arrow gard Blue PLUS Central Venous Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154605 |
| mdprc 007 05 17 000 | AngioDynamics Inc | NAMIC Fluid Delivery Sets , | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152938 |
| mdprc 006 05 17 000 | Alcon Research, Ltd | Packaged Kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154408 |
| mdprc 072 04 17 000 | Signal Medical Corporation | Soft Face "No Bounce" Mallet | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153400 |
| mdprc 070 04 17 000 | Beckman Coulter Inc | Access Ferritin Calibrators for Access Ferritin assay on the Access Immunoassay Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154369 |
| mdprc 069 04 17 000 | Keystone Dental Inc | Keystone Dental PrimaConnex Straight Implant TC | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154175 |
| mdprc 068 04 17 000 | Intuitive Surgical Inc | Da Vinci Xi EndoWrist Suction Irrigators , | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154548 |
| mdprc 067 04 17 000 | Ferno-Washington Inc | Ferno PROFlexx Model 28Z Chair Cot | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154113 |
| mdprc 066 04 17 000 | Cincinnati Sub-Zero Products Inc | Hemotherm CE, model 400CE, HeaterCooling Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154013 |
| mdprc 064 04 17 000 | Micromedics Inc | FibriJet Endoscopic Catheter Introducer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151600 |
| mdprc 063 04 17 000 | Hill-Rom, Inc. &Subsidiaries | TotalCare Bed Systems with 3-Level Patient Position Monitoring | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153395 |
| mdprc 062 04 17 000 | Aesculap | AESCULAP (FH620R) MINOP InVent 30 Trocar System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154132 |
| mdprc 061 04 17 000 | 2k Innovations Inc | Volt Resistance | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154190 |
| mdprc 060 04 17 000 | Windstone Medical Packaging, Inc. | Ophthalmic Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154151 |
| mdprc 059 04 17 000 | Welch Allyn Protocol Inc | Microlife ProBP 2400 Digital Blood Pressure Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153506 |
| mdprc 058 04 17 000 | GE Medical Systems | GE Centricity Web Diagnostic (WebDx) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116455 |
| mdprc 057 04 17 000 | Draeger Medical Systems Inc | Kappa, Delta, Delta XL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154433 |
| mdprc 055 04 17 000 | VOLCANO CORPORATION | REFINITY | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154474 |
| mdprc 053 04 17 000 | Nihon Kohden Corp | CSM1901 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154033 |
| mdprc 052 04 17 000 | Merit Medical Systems Inc | PreludeSYNC Radial Compression Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154106 |
| mdprc 051 04 17 000 | Datascope Corp | Custom Tubing Pack with Bioline Coating | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153411 |
| mdprc 050 04 17 000 | PerkinElmer Life and Analytical Sciences | Specimen Gate Laboratory | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153750 |
| mdprc 038 04 17 000 | Centurion Medical Products | OPHTHALMIC DRESSING TRAY | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154052 |
| mdprc 037 04 17 000 | Agilent Technologies, Inc. | Bond Elut Dried Matrix Spotting (DMS) cards | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153930 |
| mdprc 036 04 17 000 | Philips Healthcare | IntelliVue MX40 WLAN Patient Wearable Monitors. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153762 |
| mdprc 035 04 17 000 | Philips Burton | eCare Coordinator | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153766 |
| mdprc 033 04 17 000 | Arrow International Inc | ARROW Antimicrobial/Antithrombogenic PICC Kits | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153712 |
| mdprc 016 04 17 000 | United Orthopedic Corporation | UOC Femoral driver | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153467 |
| mdprc 015 04 17 000 | Medtronic SA | SynchroMed II implantable drug infusion pump | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153615 |
| mdprc 014 04 17 000 | Biomet 3i Inc | BIOMET 3i LTX DENTAL IMPLANTS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154241 |
| mdprc 013 04 17 000 | Zimmer inc | Altius MINI OCT Posterior Spinal Fixation System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153660 |
| mdprc 012 04 17 000 | Strata Skin Sciences, Inc. | XTRAC Excimer Laser, Model No. AL8000, AL10000 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153927 |
| mdprc 011 04 17 000 | Nonin Medical, Inc. | Nonin, 8500M Handheld Pulse Oximeter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150238 |
| mdprc 010 04 17 000 | Focus Diagnostics Inc | Legionella IFA Substrate Slide | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153688 |
| mdprc 116 03 17 000 | Terumo Cardiovascular Systems Corporation | Level Sensor II Pads | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153246 |
| mdprc 115 03 17 000 | Tearscience, Inc | LipiFlow | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152977 |
| mdprc 114 03 17 000 | Streck | CytoChex BCT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153381 |
| mdprc 113 03 17 000 | Siemens Medical Solutions | Syngo.plaza Picture Archiving and communications systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153715 |
| mdprc 111 03 17 000 | Philips Healthcare | HeartStart MRx Monitor/Defibrillators ,. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153480 |
| mdprc 110 03 17 000 | National Biological Corp | Hand Foot II | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154038 |
| mdprc 109 03 17 000 | Molded Products Inc | NonSterile Double DIN to DIN "Y" Connector | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154105 |
| mdprc 108 03 17 000 | Merit Medical Systems Inc | 7 Fr Prelude Short Sheath Introducers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153619 |
| mdprc 107 03 17 000 | Medical Components, Inc | 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153698 |
| mdprc 106 03 17 000 | Hitachi Medical Corp | Hitachi Echelon MRI System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152994 |
| mdprc 105 03 17 000 | Teleflex Medical | Rusch, Latex Free Robertazzi Airway | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152601 |
| mdprc 104 03 17 000 | Siemens Medical Solutions | ARTISTE MV System, Mevatron M2/Primus Mid Energy and PRIMUS HI, ONCOR" Avantgarde, ONCOR" Expression, Impression and Impression plus | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153976 |
| mdprc 103 03 17 000 | Revision Optics Inc | Raindrop Near Vision Inlay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153166 |
| mdprc 102 03 17 000 | Medtronic Limited | Poly Component Trial, CR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153924 |
| mdprc 101 03 17 000 | Crossroads Extremity Systems Llc | MotoCLIP(TM) Super Elastic Fusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153844 |
| mdprc 100 03 17 000 | Zimmer Biomet | Orthosize Templating | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153219 |
| mdprc 099 03 17 000 | Stanley Healthcare Solutions | Arial WaterResistant Pendant, model 59350 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152047 |
| mdprc 098 03 17 000 | Philips Healthcare | Brilliance BigBore Radiology CT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153825 |
| mdprc 097 03 17 000 | Merge Healthcare Corp. | Merge Cardio with Issuer Patient ID ( IPID) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154005 |
| mdprc 096 03 17 000 | GE Healthcare | Electri-Cord Power Cords Used with Various Incubators, Warmers, and Exam Lights: | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152634 |
| mdprc 096 12 16 001 | Vygon UK Ltd | Vygon | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153644 |
| mdprc 085 03 17 000 | Acumed LLC | Guide Wire | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153524 |
| mdprc 084 03 17 000 | Toshiba Medical Systems Corporation | Toshiba Kalare DREXKL80, Ultimax DREXULT80 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152450 |
| mdprc 083 03 17 000 | Smiths Medical International Limited | Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153205 |
| mdprc 082 03 17 000 | Maquet Cardiopulmonary AG | VASOVIEW HEMOPRO VH-3500 Endoscopic Vessel Harvesting Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152788 |
| mdprc 081 03 17 000 | Del Mar Reynolds Medical, Ltd. | Arkon Anesthesia Delivery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153199 |
| mdprc 022 11 15 001 | Encore Medical, Lp | RSP and Turon Impaction Fixtures | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153244 |
| mdprc 057 03 17 000 | CORENTEC CO., LTD | Bencox Mirabo PE Liner 36/44 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153590 |
| mdprc 056 03 17 000 | Smiths Medical ASD Inc.. | CADD Solis VIP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152490 |
| mdprc 055 03 17 000 | Siemens Medical Solutions | PRIMUS HI, MEVATRON | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153261 |
| mdprc 054 03 17 000 | RTI Surgical, Inc | RTI Biologics BioSet IC RT Paste 2 cc | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153287 |
| mdprc 110 02 17 001 | Phadia Ltd | Recall EliA Sample Diluent | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152965 |
| mdprc 033 03 17 001 | Parker Healthcare | Parker Left Double Lumen Endobronchial Tube with Parker FlexTip | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00258-1 |
| mdprc 035 03 17 000 | The See Clear Company | Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152629 |
| mdprc 034 03 17 000 | Remel | Haemophilus Test Medium | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153231 |
| mdprc 032 03 17 000 | MicroAire Surgical Instruments. | MicroAire K-Wires | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153520 |
| mdprc 031 03 17 000 | Metrex Research, LLC | CaviWipes1 Extra Large | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152763 |
| mdprc 030 03 17 000 | Medtronic SA | RF Surgical Systems Sterile Drapes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152794 |
| mdprc 019 03 17 000 | Mckesson Information Solutions LLC | McKesson Radiology 12.2 Picture Archive Communication System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153379 |
| mdprc 018 03 17 000 | Ergosafe Products LLC | A-series lift - A625 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153404 |
| mdprc 010 03 17 000 | Windstone Medical Packaging, Inc. | Gloves | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152631 |
| mdprc 009 03 17 000 | Synthes GmbH | PRODISC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153344 |
| mdprc 008 03 17 000 | Matrix Surgical | OMNIPORE Surgical Implant Design Y Mandible Onlay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152960 |
| mdprc 112 02 17 000 | Roche Diagnostics Ltd | Cobas b 123 POC system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151082 |
| mdprc 111 02 17 000 | Vascular Solutions Inc | GrebSet MicroIntroducer Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152975 |
| mdprc 109 02 17 000 | Olympus | Uretero-Reno Fiberscopes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151898 |
| mdprc 108 02 17 000 | Smith & Nephew | Dyonics Saw Blade | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153146 |
| mdprc 107 02 17 000 | Quidel Corporation | Influenza Transport Swab | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152840 |
| mdprc 106 02 17 000 | Degania Silicone, Ltd | Jackson Pratt" Channel drain | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152988 |
| mdprc 105 02 17 000 | Custom Medical Specialties, Inc | CMS2193R7 and CMS1911R3 Custom Biopsy Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152617 |
| mdprc 104 02 17 000 | Cardiovascular Systems, Inc | DIAMONDBACK 360 Peripheral Orbital Atherectomy System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152955 |
| mdprc 103 02 17 000 | Biomet Inc | Oxford Partial Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=152481 |
| mdprc 102 02 17 000 | Arrow International Inc | Arrow PICC Kits with Peel-Away Sheath Component | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152569 |
| mdprc 078 02 17 000 | Zimmer Biomet | Cranio-maxillofacial Bone Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152996 |
| mdprc 077 02 17 000 | Tosoh Corporation | Tosoh Bioscience HLC723G8 Analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151106 |
| mdprc 076 02 17 000 | Philips Healthcare | InfiniBand Cables Used with Cisco 3850 Layer 3 Switches Used with IntelliVue Information Center iX or Classic Information Centers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152105 |
| mdprc 075 02 17 000 | Biomet Inc | Vanguard Knee | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152728 |
| mdprc 074 02 17 000 | AngioDynamics Inc | Celerity PICC Tip Confirmation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149720 |
| mdprc 053 02 17 000 | Argon Medical Devices Inc | Bone Needle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152717 |
| mdprc 052 02 17 000 | Acumed LLC | 6-hole Pubic Symphysis plate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152823 |
| mdprc 051 02 17 000 | Integra LifeSciences | Integra Cadence Total Ankle System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152681 |
| mdprc 050 02 17 000 | Encore Medical, Lp | LIMA Modular Revision Hip Stem | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152523 |
| mdprc 034 02 17 000 | Vertebral Technologies, Inc | InterFuse Tail Traction Tool | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152615 |
| mdprc 033 02 17 000 | Teleflex Medical | Sheridan HVT, Cuffed, Uncuffed Tracheal Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152271 |
| mdprc 032 02 17 000 | Merge Healthcare Corp. | Merge RadSuite software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152597 |
| mdprc 031 02 17 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147282 |
| mdprc 030 02 17 000 | Physio Control Inc | LIFEPAK 12, LIFEPAK 15 Defibrillator/Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152423 |
| mdprc 017 02 17 000 | Mevion Medical Systems, Inc. | MEVION S250-Proton Radiation Therapy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152138 |
| mdprc 016 02 17 000 | Medtronic Advanced Energy, LLC | Intact Disposable Wands | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152248 |
| mdprc 015 02 17 000 | AngioDynamics Inc | Celerity PICC Tip Confirmation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149720 |
| mdprc 009 02 17 000 | Siemens Medical Solutions | Syngo.plaza, picture archiving and communications system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152622 |
| mdprc 124 01 17 000 | Zimmer inc | Orthopedic Salvage System (OSS) 9cm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152112 |
| mdprc 123 01 17 000 | Implant Direct LLC | SwishTapered Implant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152174 |
| mdprc 122 01 17 000 | Flower Orthopedics Corporation | Cannulated Drill bit 2.0mm and 2.6 mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152401 |
| mdprc 121 01 17 000 | Smiths Medical | NORMOFLO H1100 Irrigation Fluid Warmers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152491 |
| mdprc 120 01 17 000 | SCC Soft Computer | Softbank II | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152048 |
| mdprc 119 01 17 000 | PerkinElmer Life and Analytical Sciences | Spare Disk Remover Module | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152448 |
| mdprc 118 01 17 000 | Hitachi Medical Corp | Hitachi Oasis MRI System CSpine Coil | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152058 |
| mdprc 117 01 17 000 | Biom'up | RENOVIX Guided Healing Collagen Membrane | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152768 |
| mdprc 107 01 17 000 | Baxter Healthcare | Phoenix Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152438 |
| mdprc 106 01 17 000 | Acumedia Manufacturers, Inc | Neogen | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152054 |
| mdprc 105 01 17 000 | Roche Diagnostics Corp | TinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151085 |
| mdprc 097 01 17 000 | Sekisui Diagnostics | Ammonia L3K Assay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151386 |
| mdprc 096 01 17 000 | PENTAX Europe GmbH | Pentax Rigid Laryngostroboscopes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152137 |
| mdprc 095 01 17 000 | Medtronic Navigation Inc | Touch N Go pointer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152061 |
| mdprc 094 01 17 000 | Medline Industries Inc | E-Z Lubricating Jelly | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151810 |
| mdprc 093 01 17 000 | INO Therapeutics (dba Ikaria) | INOmax DSIR Plus delivery system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151520 |
| mdprc 092 01 17 000 | Philips Burton | Brilliance iCT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152295 |
| mdprc 091 01 17 000 | On-X Life Technologies, Inc | ChordX Chordal Sizer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151822 |
| mdprc 090 01 17 000 | The Binding Site | Digital RID Plate Reader | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152040 |
| mdprc 089 01 17 000 | Great Basin Scientific, Inc | Great Basin Staph lD/R Blood Culture Panel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152100 |
| mdprc 088 01 17 000 | DICOM GRID INC | Ambra PACS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152488 |
| mdprc 087 01 17 000 | Carestream Health | Carestream Touch Prime and Carestream Touch Prime XE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152532 |
| mdprc 086 01 17 000 | CareFusion.. | Model 8100 Alaris Pump Modules and Air-in-Line Sensor Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150442 |
| mdprc 085 01 17 000 | Bard Pcripheral Vascular (BPV) | Halo One ThinWalled Guiding Sheath | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151513 |
| mdprc 075 01 17 000 | Zimmer inc | ArComXL Polyethylene Bearings and Liners | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151858 |
| mdprc 074 01 17 000 | Ultradent Products, Inc | NanoTips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152022 |
| mdprc 073 01 17 000 | Stryker Howmedica Osteonics Corp | Reunion TSA Peg Alignment Sound, Stryker Orthopaedics | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151592 |
| mdprc 072 01 17 000 | Fresenius Medical Care. | Fresenius Home Dialysis System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152020 |
| mdprc 071 01 17 000 | Exactech | Alteon Neck Preserving Stem, AcuMatch ASeries Connexion GXL Enhanced Polyethylene Acetabular Liner, Novation Cemented Plus Femoral Stem | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151892 |
| mdprc 070 01 17 000 | Health Robotics | i.v.STATION ONCO Automated Drug Compounding Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152440 |
| mdprc 069 01 17 000 | ConforMIS | iTotal PS Knee Replacement System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151856 |
| mdprc 068 01 17 000 | Bard Access Systems | SafeStep Huber Needle Set with YInjection Site and MiniLoc Safety Infusion Set Winged without YInjection Site | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151928 |
| mdprc 060 01 17 000 | Alcon Research, Ltd | Alcon Monarch III (1) "C" Cartridge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149191 |
| mdprc 059 01 17 000 | Amendia, Inc | Ceres-C Standalone Cervical Interbody | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151460 |
| mdprc 058 01 17 000 | Advanced Sterilization Products | EVOTECH Endoscope Cleaner and Reprocessor System 208V, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149985 |
| mdprc 057 01 17 000 | Implant Direct LLC | GoDirect Screw-Retaining Top | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151437 |
| mdprc 051 01 17 000 | Trilliant Surgical Ltd | Tiger Cannulated Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151974 |
| mdprc 048 01 17 000 | In2Bones, SAS | DRP SCREW | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152164 |
| mdprc 047 01 17 000 | Natus Medical Inc. | Warmette Blanket Cabinet and Warmette Dual Cabinet | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151447 |
| mdprc 046 01 17 000 | Voco | VOCO Futurabond M adhesive | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151254 |
| mdprc 035 01 17 000 | Infraredx, Inc. | TVC Imaging System model TVC-MC9 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151938 |
| mdprc 034 01 17 000 | Pride Mobility Products Ltd | TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151534 |
| mdprc 033 01 17 000 | Tepha Incorporated | GalaSHAPE 3D | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151792 |
| mdprc 032 01 17 000 | Merit Medical Systems Inc | PreludeEASE Dilators Used with 6 Fr PreludeEASE Hydrophilic Sheath Introducers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151906 |
| mdprc 031 01 17 000 | Aesculap | Gomco Circumcision Clamps with separate ORing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151777 |
| mdprc 124 12 16 000 | Neusoft Medical System Co | NeuViz 128, NeuViz 64 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150175 |
| mdprc 123 12 16 000 | Synthes Inc | Synthes VA Implant Rack for the Compact Distal Radius System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151426 |
| mdprc 122 12 16 000 | Stryker Communications | MIS (Minimally Invasive Surgery) Toolsteel Burs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151387 |
| mdprc 121 12 16 000 | Owens & Minor | Arm Sling | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150987 |
| mdprc 120 12 16 000 | PerkinElmer Life and Analytical Sciences | Specimen Gate Laboratory eReports | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151383 |
| mdprc 119 12 16 000 | Northgate | Insufflator, laparoscopic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151095 |
| mdprc 118 12 16 000 | Medtronic Advanced Energy, LLC | PowerCross .018 OTW PTA Dilation Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151248 |
| mdprc 112 12 16 000 | Philips Medical Systems | Brilliance and Ingenuity Computed Tomography Xray system.. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142085 |
| mdprc 097 12 16 000 | Medtronic Advanced Energy, LLC | SynchroMed II Implantable Drug Infusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150480 |
| mdprc 095 12 16 000 | Teleflex Medical | RUSCH | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151249 |
| mdprc 094 12 16 000 | Natus Medical Inc. | Natus neoBLUE blanket LED Phototherapy system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147989 |
| mdprc 093 12 16 000 | Firefly Medical, Inc | IVEA 500A | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150828 |
| mdprc 084 12 16 000 | Stryker Sustainability Solutions | Reprocessed Xcel Bladeless Trocar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151030 |
| mdprc 083 12 16 000 | Roche Diagnostics Ltd | Roche Molecular Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151271 |
| mdprc 082 12 16 000 | PENTAX Europe GmbH | Ultrasound Video Bronchoscope | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149791 |
| mdprc 081 12 16 000 | Olympus Winter & IBE GmbH | HF Cable WA00014A | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150883 |
| mdprc 080 12 16 000 | Oculus Innovative Sciences Inc | Ceramax Skin Barrier Cream, FROWound cleanser/ Dressing, wound, drug | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151214 |
| mdprc 079 12 16 000 | Inovo, Inc | Purefill Oxygen Compressor, model PF1100 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150020 |
| mdprc 078 12 16 000 | Covidien LLC | Covidien Precision Specimen Containers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150473 |
| mdprc 071 12 16 000 | PerkinElmer Life and Analytical Sciences | Pipette tips, Perkin Elmer RoboRack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150563 |
| mdprc 070 12 16 000 | Steris Corp | Harmony Insight Diagnostic Monitor Support System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150180 |
| mdprc 069 12 16 000 | GF Health Products | Patriot Full Electric Homecare Beds, Patriot LX Full Electric Homecare Beds | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150433 |
| mdprc 068 12 16 000 | Cook Medical | Spectrum Minocycline/Rifampin Impregnated Central Venous Catheter Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151288 |
| mdprc 067 12 16 000 | Becton Dickinson & Co. (BD) | BD Spinal Anesthesia Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151303 |
| mdprc 053 12 16 000 | SynCardia Systems Inc | SynCardia Freedom Driver System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150882 |
| mdprc 052 12 16 000 | Randox Laboratories Ltd | Magnesium Assays used with Rx Imola Analyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149845 |
| mdprc 051 12 16 000 | Prism Medical Ltd | C-Series Ceiling Lifts Carry Bars | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147755 |
| mdprc 050 12 16 000 | Halyard Health Co. | C-Section Drape with Clear Screen or Pouch | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151051 |
| mdprc 048 12 16 000 | Elekta CMS Software | MOSAIQ Oncology Information System.. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151455 |
| mdprc 047 12 16 000 | Olympus | VANTA Analytical X-Ray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150838 |
| mdprc 040 12 16 000 | Merge Healthcare Corp. | eFilm Workstation and eFilm Lite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149867 |
| mdprc 039 12 16 000 | Ivoclar Vivadent AG | Virtual XD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150948 |
| mdprc 038 12 16 000 | DeRoyal Europe Ltd | TENNIS ELBOW SUPPORT, PneuGel(TM), | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151016 |
| mdprc 037 12 16 000 | AngioDynamics Inc | BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit and Xcela Power Injectable PICC Maximal Barrier Nursing Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150100 |
| mdprc 036 12 16 000 | AngioDynamics Inc. | Peripherally Inserted Central Catheters (PICC) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148877 |
| mdprc 028 12 16 000 | Thayer Intellectual Property, Inc. | MANOS EX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150962 |
| mdprc 027 12 16 000 | Tornier Inc. | Aequalis Fx2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150330 |
| mdprc 026 12 16 000 | Terumo BCT Inc. | Adiprep Adipose Transfer System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150857 |
| mdprc 025 12 16 000 | Sorin Group | STOCKERT HeaterCooler System 3T | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150831 |
| mdprc 024 12 16 000 | Elana Inc. | Elana Surgical KitHUD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150965 |
| mdprc 022 12 16 000 | Domain Surgical, Inc. | FMsealer Open Shears | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150959 |
| mdprc 021 12 16 000 | DePuySynthes | Stryker J-Latch Drill Bits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151063 |
| mdprc 004 12 16 000 | Spectranetics Corporation | ELCA Coronary and Turbo Elite Atherectomy Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150921 |
| mdprc 003 12 16 000 | SIEMENS | Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150975 |
| mdprc 002 12 16 000 | Hamilton Medical Inc. | Hamilton-MR1 Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150064 |
| mdprc 167 11 16 000 | Roche Diagnostics Ltd | Handheld Base Unit for CoaguChek XS Plus and CoaguChek XS Pro Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150869 |
| mdprc 166 11 16 000 | Lsi Medience Corporation | Pathfast D-Dimer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150602 |
| mdprc 165 11 16 000 | Hologic Inc. | SureSound + Uterine Sound Device Multipacks | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150787 |
| mdprc 164 11 16 000 | DePuy International Ltd | ACTIS Flex Reamers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150760 |
| mdprc 163 11 16 000 | ConforMIS | ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150776 |
| mdprc 162 11 16 000 | Cincinnati Sub-Zero Products Inc. | The Hemotherm 400CE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150976 |
| mdprc 161 11 16 000 | Bausch & Lomb Inc. | PeroxiClear Peroxide Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150049 |
| mdprc 154 11 16 000 | Merit Medical Systems Inc. | Custom Fluid Management Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149111 |
| mdprc 153 11 16 000 | Trilliant Surgical Ltd | Tiger Large Cannulated Headless Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149612 |
| mdprc 152 11 16 000 | Sorin | ORCHESTRA Programmer and ORCHESTRA PLUS Programmer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150425 |
| mdprc 151 11 16 000 | SIEMENS | SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151034 |
| mdprc 150 11 16 000 | Mevion Medical Systems, Inc. | MEVION S250 Radiation Therapy Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150527 |
| mdprc 149 11 16 000 | Merge Healthcare Corp. | Merge RadSuite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149859 |
| mdprc 148 11 16 000 | DePuy Spine, Inc. | SKYLINE Variable and Constrained Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150407 |
| mdprc 147 11 16 000 | C R Bard Inc. | Magic3 Antibacterial Hydrophilic Intermittent Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150148 |
| mdprc 146 11 16 000 | Alphatec Spine Inc. | Set Screws Used with Arsenal Spinal Fixation Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150094 |
| mdprc 145 11 16 000 | Alere | Alere Triage Total 5 Control Level 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150328 |
| mdprc 133 11 16 000 | Reshape Medical Inc. | ReShape Integrated Dual Balloon System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150463 |
| mdprc 131 11 16 000 | Bayer Healthcare LLC. | MEDRAD Intego PET Infusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150186 |
| mdprc 130 11 16 000 | Stryker | Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150221 |
| mdprc 129 11 16 000 | Medline Industries Inc. | Rigid Suction Canister 3000 CC and 2000 CC. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149428 |
| mdprc 128 11 16 000 | Akita Sumitomo Bakelite Co., Ltd. | SB (Sumitomo Bakelite Co.,) Electrosurgical Knife | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150181 |
| mdprc 102 11 16 000 | Arrow International Inc | HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150156 |
| mdprc 101 11 16 000 | Azer Scientific, Inc. | Glucose Tolerance Beverage, Fruit Punch Glucose | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149271 |
| mdprc 100 11 16 000 | B Braun Medical Inc | Hospira 5% Lidocaine Hydrochloride and 7.5% Dextrose Injections Contained in Custom Spinal Anesthesia Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148668 |
| mdprc 099 11 16 000 | Spacelabs Healthcare Inc | Model 96102 Xhibit Central Stations | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150467 |
| mdprc 092 11 16 000 | TEM Systems Inc | ex-TEM Assay for ROTEM delta Thromboelastometry System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149847 |
| mdprc 090 11 16 000 | Epimed International Inc | 15 G R.K. Epidural Needles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145925 |
| mdprc 088 11 16 000 | Medtronic Inc | Visualase Visualization Stylets and Body Accessory Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149419 |
| mdprc 086 11 16 000 | BBI Solutions | SimpliRED D-Dimer Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148459 |
| mdprc 061 11 16 000 | US Endoscopy | Vari-Safe Injection Needle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147998 |
| mdprc 060 11 16 000 | TZ Medical Inc. | Neptune Plus (Hemostatic Pad) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148503 |
| mdprc 059 11 16 000 | Ortho-Clinical Diagnostics | EnGen Laboratory Automation Systems Configured with Thermo Scientific Centrifuge Modules | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149527 |
| mdprc 058 11 16 000 | Olympus | OER-Pro Automated Endoscope Reprocessors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147873 |
| mdprc 053 11 16 000 | Tearscience, Inc | LipiFlow thermal Pulsation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149494 |
| mdprc 052 11 16 000 | Synergetics Inc. | 25 gauge VersaVit 2.0 Core Essentials Procedure Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148781 |
| mdprc 051 11 16 000 | Osteogenics Biomedical, Inc. | Cytoplast Titanium-Reinforced Posterior Singles Membrane | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149396 |
| mdprc 050 11 16 000 | Hand Biomechanics Lab Inc. | Agee- WristJack Fracture Reduction System; | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149824 |
| mdprc 049 11 16 000 | Becton Dickinson & Co. (BD) | CD79b PE (ASR) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149794 |
| mdprc 048 11 16 000 | Zimmer Inc. | Uniflex Humeral Nails | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149723 |
| mdprc 047 11 16 000 | Zimmer inc | The Phoenix Femoral Nail System . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149728 |
| mdprc 028 11 16 000 | Winco, Inc. | TransMotion Stretcher Chair | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148797 |
| mdprc 027 11 16 000 | Medtronic SA | Medtronic Navigation O-arm O2 Surgical Imaging System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149921 |
| mdprc 026 11 16 000 | BOMImed Inc. | Introes Pocket Bougies | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149464 |
| mdprc 025 11 16 000 | Becton Dickinson & Co. (BD) | V. Mueller Sterile Distraction Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149995 |
| mdprc 024 11 16 000 | Banyan Medical, LLC | 5 x 55mm Pyramidal Tip Trocar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149913 |
| mdprc 023 11 16 000 | Zimmer Inc. | LDR Spine ROI-A Anterior Delivery Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149274 |
| mdprc 022 11 16 000 | Toshiba Medical Systems Corporation | Aquilion and Celesteion CT Scanners | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148646 |
| mdprc 021 11 16 000 | Teleflex Medical | Gripper Graspers and Johans Graspers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149434 |
| mdprc 020 11 16 000 | Siemens Medical Solutions | Symbia T and Symbia S Series CT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122573 |
| mdprc 019 11 16 000 | Natus Medical Incorporated | NatalCare ST-LX Incubators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148064 |
| mdprc 018 11 16 000 | Argon Medical Devices Inc. | MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149676 |
| mdprc 167 10 16 000 | Zimmer Biomet, Inc. | Vanguard 360 Revision Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149732 |
| mdprc 165 10 16 000 | Teleflex Medical | Willy Rusch GmbH Tracheostomy Tube Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149196 |
| mdprc 164 10 16 000 | Merit Medical Systems Inc | Merit Inflation Syringe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149424 |
| mdprc 163 10 16 000 | HeartWare Inc | HeartWare Ventricular Assist System Controller | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146078 |
| mdprc 162 10 16 000 | Sorin Group | Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148853 |
| mdprc 158 10 16 000 | Arrow International Inc. | Walrus Arterial Embolectomy Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149374 |
| mdprc 157 10 16 000 | Philips Healthcare | Various Brilliance and Ingenuity Computed Tomography Systems.. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140467 |
| mdprc 156 10 16 000 | Medtronic | CareLink iPro Version 1.10 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148899 |
| mdprc 130 10 16 000 | Zyno Medical LLC | Zyno Medical Administration Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148698 |
| mdprc 129 10 16 000 | EKOS Corp | EkoSonic Endovascular System Carts | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149355 |
| mdprc 128 10 16 000 | Microgenics Corp. | DRI Salicylate Serum Tox Assay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148620 |
| mdprc 127 10 16 000 | Trividia Health (formerly Nipro Diagnostics) | TRUEread , TRUEtrack , TRUEbalance and TRUEtest Blood Glucose Test Strips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148492 |
| mdprc 110 10 16 000 | Philips Medical Systems | Brilliance CT System, Big Bore Configuration | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129644 |
| mdprc 109 10 16 000 | SIEMENS | Syngo Plaza picture archiving and communication system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149421 |
| mdprc 106 10 16 000 | SIEMENS | Syngo.x and Syngo.via picture archiving and communication systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149459 |
| mdprc 104 10 16 000 | TriMed Ortho | Semi-Tubular Plates | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149324 |
| mdprc 103 10 16 000 | Sorin Group | Stockert S5 Heart-Lung Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149150 |
| mdprc 102 10 16 000 | OrthoPediatrics Corp | 3.5mm Bowed Locking Compression Femur Plates | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149114 |
| mdprc 101 10 16 000 | Ortho Solutions | FPS 35mm x 3.5 mm non-locking screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148595 |
| mdprc 100 10 16 000 | Integra LifeSciences | PHS Spinal Tray 24G Gertie Marx | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149139 |
| mdprc 099 10 16 000 | Hologic Inc. | Sertera Biopsy Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149028 |
| mdprc 076 10 16 000 | Merge Healthcare Corp | RadSuite software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148661 |
| mdprc 075 10 16 000 | C R Bard Inc. | Option-vm and Option-vf Urinary Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148280 |
| mdprc 074 10 16 000 | Alcon Laboratories Inc. | LAUREATE World Phaco System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148531 |
| mdprc 073 10 16 000 | AirStrip Technologies, Inc. | The Sense4Baby System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148904 |
| mdprc 072 10 16 000 | AirStrip Technologies, Inc. | The Sense4Baby System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148904 |
| mdprc 063 10 16 000 | Thermo Fisher Scientific Inc. | Endura MR Mass Spectrometer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148564 |
| mdprc 062 10 16 000 | Mentor Texas Inc. | CPX4 and Artoura Breast Tissue Expander | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148715 |
| mdprc 061 10 16 000 | T2 Biosystems | T2Candida Cartridges | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148334 |
| mdprc 060 10 16 000 | Stryker Howmedica Osteonics | T2 Femoral Nailing System and T2 Supracondylar Nail System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148300 |
| mdprc 059 10 16 000 | Stryker Howmedica Osteonics Corp | Stryker AccuLIF PL Cages | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148845 |
| mdprc 009 10 16 000 | Sysmex America Inc. | Fluorocell PLT Hematology Reagents Used with XN-Series Automated Hematology Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148122 |
| mdprc 008 10 16 000 | Integra LifeSciences | Integra Meshed Dermal Regeneration Template | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144759 |
| mdprc 007 10 16 000 | Hologic Inc. | SureSight Obturator Introducer Localization System Sets Used with ATEC Breast Biopsy Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148567 |
| mdprc 006 10 16 000 | Arrow International Inc. | Multiple Arrow catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148712 |
| mdprc 049 09 16 000 | Zimmer Inc. | Coonrad/Morrey Elbow Pin/Bushing Replacement Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149116 |
| mdprc 048 09 16 000 | Riverpoint Medical, LLC | Nylon Surgical Suture and Polypropylene Surgical Sutures | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148695 |
| mdprc 047 09 16 000 | Novadaq Technologies Inc. | SK6000 PAQ Sterile Drape Pouches Used with SPY Fluorescence Imaging Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149092 |
| mdprc 046 09 16 000 | Hill Rom | Affinity Four Birthing Bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148397 |
| mdprc 045 09 16 000 | Blackrock Microsystems | Neural Signal Amplifiers and Patient Cables Used with NeuroPort Biopotential Signal Processing Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148706 |
| mdprc 044 09 16 000 | Aspen Surgical Products, Inc. | Bard-Parker 12B Conventional Stainless Steel Surgical Blades | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147986 |
| mdprc 031 09 16 000 | Mentor Texas Inc. | MENTOR 2" Tall Height TE With Sutures 350cc | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148700 |
| mdprc 030 09 16 000 | Integra LifeSciences | Integra Cranial Access Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149138 |
| mdprc 029 09 16 000 | Topcon | PASCAL Synthesis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148296 |
| mdprc 028 09 16 000 | Merge Healthcare Corp. | Merge Cardio software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149136 |
| mdprc 027 09 16 000 | Elekta Limited | Precise Digital Accelerator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149195 |
| mdprc 011 09 16 000 | Terumo Cardiovascular Systems | Terumo Custom Cardiovascular Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148609 |
| mdprc 009 09 16 000 | Medical Vision Ab | Double Pump RF Patient Cassette | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146681 |
| mdprc 008 09 16 000 | Mindray | A7 Anesthesia Delivery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148395 |
| mdprc 006 09 16 000 | Integra LifeSciences | INTEGRA Spinal Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148639 |
| mdprc 005 09 16 000 | Philips Healthcare | Power Supplies Used with PCR Compano Basic Digital Imaging Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148782 |
| mdprc 003 09 16 000 | Hitachi Medical Corp | Hitachi Scenaria Computed Tomography System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148276 |
| mdprc 002 09 16 000 | DeRoyal Industries Inc. | CYSTO TRAY | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148841 |
| mdprc 001 09 16 000 | Novarad Corporation | NovaPACS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148855 |
| mdprc 148 08 16 000 | Bovie Medical Corporation | Bovie Precise 360 Handpiece | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148466 |
| mdprc 147 08 16 000 | Ziehm Imaging GmbH. | Ziehm Vision RFD, Vision RFD Mo, Vision RFD 3D, Vision2, Solo and Vision R Mobile C-arm for Mobile Fluoroscopic Imaging | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145913 |
| mdprc 131 08 16 000 | GE Healthcare | OEC UroView 2800 and OEC 9800 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148502 |
| mdprc 130 08 16 000 | Stryker Instruments. | 120 V Neptune 3 Rover | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148396 |
| mdprc 129 08 16 000 | Merge Healthcare Corp. | RadSuite software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148776 |
| mdprc 128 08 16 000 | American National Mfg Inc | Panacea Air Pro Mattress Control Unit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148350 |
| mdprc 127 08 16 000 | Medtronic | Lead Kit for DBS Stimulation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147876 |
| mdprc 126 08 16 000 | Richard Wolf GmbH | Conical portio adapter (acorn) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148125 |
| mdprc 125 08 16 000 | Alere | Alere INRatio and INRatio2 PT/INR Home Monitoring System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148145 |
| mdprc 123 08 16 000 | Encore Medical, Lp | Cobalt HV Bone Cement . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148478 |
| mdprc 092 08 16 000 | ResMed SA | Quattro Air FFM MED AMER | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148349 |
| mdprc 091 08 16 000 | OraSure Technologies, Inc. | OraQuick Ebola Rapid Antigen Test | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148583 |
| mdprc 090 08 16 000 | Merge Healthcare Corp. | Merge Unity Z3D software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148592 |
| mdprc 089 08 16 000 | GE Healthcare | GE Centricity PACS Workstation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117066 |
| mdprc 088 08 16 000 | Cepheid | Xpert MRSA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148487 |
| mdprc 087 08 16 000 | Teleflex Medical | Weck EFx Classic Fascial Closure System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148177 |
| mdprc 086 08 16 000 | Straumann USA, LLC | Straumann Bone Level Implant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148476 |
| mdprc 085 08 16 000 | Medtronic Cardiovascular Revascularization & Surgical Therap | TRYX Neuro Absorbable Antibacterial Envelope | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148164 |
| mdprc 084 08 16 000 | Danville Materials, Inc | Perioscopy Sheath | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147855 |
| mdprc 083 08 16 000 | Stryker | Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148055 |
| mdprc 082 08 16 000 | Coloplast | Genesis Malleable Penile Prosthesis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135724 |
| mdprc 074 08 16 000 | Integra LifeSciences | Integra External Fixation System Slotted Post and Universal Wire Fixation Bolt | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148491 |
| mdprc 073 08 16 000 | Halyard Health Co. | Coolife Sinergy Radiofrequency | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147894 |
| mdprc 068 08 16 000 | Teleflex Medical | Servo Humidifier 163 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148176 |
| mdprc 059 08 16 000 | Richard-Allan Scientific | 10% Neutral Buffered Formalin | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147901 |
| mdprc 058 08 16 000 | SIEMENS | Artis zee/ zeego, Artis Q/ Q.zen, stand alone system. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148124 |
| mdprc 057 08 16 000 | Dako Denmark A/S | EnVision FLEX+, Mouse, High pH (Link) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148026 |
| mdprc 056 08 16 000 | Teleflex Medical | Horizon 24 Large Titanium Clips with Adhesive Backing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148156 |
| mdprc 054 08 16 000 | Stryker | Spirit Select and Spirit Plus A-C powered hospital beds | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148254 |
| mdprc 047 08 16 000 | Cardinal Health | 6F/7F MynxGrip Vascular Closure Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148244 |
| mdprc 016 08 16 000 | Implant Direct Sybron Manufacturing, LLC | RePlant Angled Abutment | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148061 |
| mdprc 005 08 16 000 | Smith & Nephew | REFLECTION Spherical Head Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148051 |
| mdprc 004 08 16 000 | Olympus | Analytical X-Ray Fluorescence Systems of model family Delta | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148001 |
| mdprc 003 08 16 000 | Moller Vital | Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147850 |
| mdprc 002 08 16 000 | Merge Healthcare Corp. | Merge PACS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148106 |
| mdprc 001 08 16 000 | GE Healthcare | Imagecast PACS with Centricity RIS-IC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117002 |
| mdprc 158 07 16 000 | The Anspach Effort, Inc. | Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147607 |
| mdprc 157 07 16 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products Ca Slides | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147262 |
| mdprc 156 07 16 000 | GE Inspection Technologies | Phoenix vtomex m240 cabinet x-ray systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147897 |
| mdprc 155 07 16 000 | CareFusion | DIAMOND-FLEX CIRCULAR RETRACTOR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147639 |
| mdprc 154 07 16 000 | BEST THERATRONICS LTD | Best Theratronics cabinet x-ray systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148078 |
| mdprc 153 07 16 000 | BD Biosciences | BD Trucount Tubes. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147864 |
| mdprc 152 07 16 000 | Zimmer Biomet | TSP Hip Fracture Plating System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147936 |
| mdprc 150 07 16 000 | WalkMed Infusion, LLC | Triton Infusion Pump and Triton FP Infusion Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147529 |
| mdprc 149 07 16 000 | Toshiba Medical Systems Corporation | Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147685 |
| mdprc 148 07 16 000 | Steris Corp | OT1000 Series Orthopedic Surgical Tables | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147015 |
| mdprc 147 07 16 000 | SIEMENS | Syngo.via, picture archiving and communications system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148056 |
| mdprc 146 07 16 000 | Parks Medical | Parker Trach-Vac Endotracheal Tubes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147877 |
| mdprc 144 07 16 000 | Hologic Inc. | ATEC CANISTER | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147096 |
| mdprc 142 07 16 000 | Encore Medical, Lp | Linear Hip Neck Trials | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147751 |
| mdprc 141 07 16 000 | DeVilbiss Healthcare LLC | DeVilbiss Model 7305P-D Powered Suction Unit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147116 |
| mdprc 140 07 16 000 | Carestream Health | Carestream Touch Prime | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148112 |
| mdprc 106 07 16 000 | Terumo Cardiovascular Systems Corporation | HX2 Temperature Management Systems and The Sarns Temperature Control and Monitor unit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147333 |
| mdprc 105 07 16 000 | Stryker Instruments | 6.0mm and 5.0mm Round Fluted Bur | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147988 |
| mdprc 104 07 16 000 | Roche Diagnostics Corp | Cobas Liat Analyzer. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146266 |
| mdprc 103 07 16 000 | Devicor Medical Products,Inc. | Mammotome Revolve Dual Vacuum Assist Biopsy System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147103 |
| mdprc 077 07 16 000 | Varian Medical Systems | TrueBeam EDGE, Optical Surface Monitoring System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147985 |
| mdprc 076 07 16 000 | Novarad Corporation | NovaPACS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147900 |
| mdprc 075 07 16 000 | Arrow International Inc. | Femoral Arterial Line | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147757 |
| mdprc 064 07 16 000 | Synthes Inc. | Ti Button Plate , Matrix Neuro Screwdriver Blade and Low Profile Neuro Screwdriver Blade | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147490 |
| mdprc 063 07 16 000 | Toshiba American Medical Systems Inc. | Vantage Titan 3T MRI System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147627 |
| mdprc 061 07 16 000 | Sorin Group | AORTIC ARCH CANNULA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147758 |
| mdprc 060 07 16 000 | Philips Healthcare | Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124851 |
| mdprc 059 07 16 000 | Medtronic Navigation Inc. | Medtronic Navigation O-arm 02 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147271 |
| mdprc 058 07 16 000 | Medtronic Navigation Inc. | Medtronic 0-arm Imaging mobile x-ray system. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146523 |
| mdprc 057 07 16 000 | Lifeline First Aid LLC | First Aid Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147244 |
| mdprc 056 07 16 000 | Hardy Diagnostics | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147263 |
| mdprc 055 07 16 000 | Exactech | Novation Press-Fit Splined RDD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147140 |
| mdprc 054 07 16 000 | Custom Ultrasonics, Inc | The System 83 Plus, Endoscope Washer/Disinfector | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147130 |
| mdprc 053 07 16 000 | Arrow International Inc. | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147271 |
| mdprc 036 07 16 000 | Siemens Medical Solutions | Syngo.plaza | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147343 |
| mdprc 035 07 16 000 | Physio Control Inc | LIFEPAK CR Plus and LIFEPAK EXPRESS Automatic External Defibrillators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146712 |
| mdprc 034 07 16 000 | PENTAX Europe GmbH | PENTAX—Reusable Water Bottle Assemblies Used with Video Processors, Light Sources, and Endoscopes with Air/Water Channels | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145337 |
| mdprc 033 07 16 000 | Medtest Holdings, Inc | Liquid Stable 2Part Homocysteine Reagent | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146910 |
| mdprc 032 07 16 000 | Hospira Inc | LIifeShield CLAVE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122209 |
| mdprc 031 07 16 000 | Dynarex Corporation | dynarex Specimen Containers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144534 |
| mdprc 030 07 16 000 | CMP Industries, Llc | IMPAK Liquid Acrylic Resin | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146129 |
| mdprc 029 07 16 000 | CareFusion.. | Model 8015 Alaris Infusion System PC Units. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146476 |
| mdprc 028 07 16 000 | Alcon Grieshaber AG. | phacofragmentation system, CENTURION Vision System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147055 |
| mdprc 018 07 16 000 | Nephron Corp | Nephron Sodium Chloride Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144035 |
| mdprc 017 07 16 000 | Implant Direct LLC | InterActive Implant OpenTray Transfer Narrow | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146782 |
| mdprc 016 07 16 000 | EV3 Inc | EV3 EverFiex Selfexpanding Peripheral Stent System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147048 |
| mdprc 015 07 16 000 | Circulatory Technology Inc | BBB38 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144568 |
| mdprc 014 07 16 000 | Ceg Enterprises Llc | Germ Terminator Toothbrush Steam Sterilization | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145923 |
| mdprc 095 06 16 000 | SIEMENS | Biograph mCT Positron Emission Tomography and Computed Tomography Systems. . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146913 |
| mdprc 094 06 16 000 | Physio-Control Inc. | LIFEPAK15 monitor/defibrillator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144259 |
| mdprc 090 06 16 000 | Nico Corp | Myriad System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146888 |
| mdprc 087 06 16 000 | Natus Medical Inc. | Natus neoBLUE Phototherapy system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143307 |
| mdprc 080 06 16 000 | Fresenius Medical Care. | Crit Line in a Clip (CLiC). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146919 |
| mdprc 079 06 16 000 | Excelsior Medical Corp | Excelsior Disposable Syringe Heparin Lock Flush | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146056 |
| mdprc 078 06 16 000 | Ethicon Endo Surgery Inc. | EVARREST Fibrin Sealant Patch | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145857 |
| mdprc 077 06 16 000 | Cell Marque Corporation | SIOOA I (EP I84) Rabbit Monoclonal Antibody | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146611 |
| mdprc 076 06 16 000 | CarboFix Orthopedics, Ltd | Piccolo Composite Tibia and Femoral Nailing Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146900 |
| mdprc 075 06 16 000 | Arthrex Inc. | BioSync Anatomic Cotton Wedge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146246 |
| mdprc 058 06 16 000 | Teleflex Medical | Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146015 |
| mdprc 057 06 16 000 | Sysmex Corporation | Sysmex XN10 and XN20 Hematology Analyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132191 |
| mdprc 056 06 16 000 | Synthes | LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146232 |
| mdprc 055 06 16 000 | Synthes Inc. | Norian Drillable Inject Bone Void Filler | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146596 |
| mdprc 054 06 16 000 | Materialise USA LLC | Signature Personalized Patient Care System . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146807 |
| mdprc 053 06 16 000 | Becton Dickinson & Co. (BD) | Henry Schein Single Use Syringe Luer-Lock, 10 mL | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145062 |
| mdprc 044 06 16 000 | Beckman Coulter Inc | Lactate OSR6x93, acid OSR6x98, Cholesterol OSR6x16, Triglyceride OSR6x118 and Lipase OSR6x30 Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145427 |
| mdprc 043 06 16 000 | DePuySynthes | 1.5 mm RAPIDSORB Rapid Resorbable Orbital Floor Plates with Bending Templates | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146069 |
| mdprc 042 06 16 000 | Integrated Science Systems Inc | Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146458 |
| mdprc 041 06 16 000 | Medical Components, Inc | Tearaway Introducer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146602 |
| mdprc 040 06 16 000 | Sedecal S.A | Sedecal SA Mobile Diagnost w DR x-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146293 |
| mdprc 039 06 16 000 | Stryker | Stryker FlowPort II Adapter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146181 |
| mdprc 028 06 16 000 | Windstone Medical Packaging, Inc. | .Multiple surgical pack.. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144842 |
| mdprc 027 06 16 000 | Ventlab Corp | STAT-Check Resuscitation Bag | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144926 |
| mdprc 026 06 16 000 | Natus Medical Inc | Replacement HEPA filter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145885 |
| mdprc 025 06 16 000 | Exactech | Femoral Stem and Acetabular Cup | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146149 |
| mdprc 024 06 16 000 | Integra York | Miltex Premium Grade Self-Lock Chisel Blade Handle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146227 |
| mdprc 010 06 16 000 | Sterilmed | Reprocessed Microline Scissor Tips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145714 |
| mdprc 009 06 16 000 | Skytron LLC | Skytron EZ Slide Operating Table | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146394 |
| mdprc 008 06 16 000 | Skytron LLC | Ergon III Series Articulating Equipment Boom Flatscreen Monitor Brackets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144784 |
| mdprc 007 06 16 000 | Olympus | Model TJF-160F/VF Duodenoscopes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144647 |
| mdprc 006 06 16 000 | MicroAire Surgical Instruments | Pneumatic Impactor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144676 |
| mdprc 005 06 16 000 | Medscience Inc | AllergiEnd ST9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST9 Multiple Well Test Tra | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144685 |
| mdprc 004 06 16 000 | Integra LifeSciences Ltd | Miltex Premium Grade SelfLocking Chisel Blade Handle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146227 |
| mdprc 003 06 16 000 | Baxter Healthcare. | COSEAL Surgical Sealant Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146452 |
| mdprc 167 05 16 000 | American Surgical Company | American Surgical Various devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145262 |
| mdprc 158 05 16 000 | Stryker | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145823 |
| mdprc 157 05 16 000 | Valeant Pharmaceuticals North America LLC | Orapharma (Onpharma) Onset Mixing Pen Rx only | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144726 |
| mdprc 156 05 16 000 | Biomet Inc | PerFuse Decompression Instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146013 |
| mdprc 155 05 16 000 | Diamedix Corporation | Diamedix Is-CMV IgG Test Kit. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145394 |
| mdprc 113 05 16 000 | Zimmer inc | Various Sterile-Packaged Hip and Trauma Implant Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145990 |
| mdprc 112 05 16 000 | Monteris Medical Corp | NeuroBiate System SideFireTM Select 2.2 mm Directional Laser Probe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145141 |
| mdprc 111 05 16 000 | Hummingbird Medical | ABG-HM-1 Hummi Micro Draw Blood Transfer Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140711 |
| mdprc 110 05 16 000 | B Braun Surgical SA | 90° Huber Needle and Wing Contained in WHIN Infusion Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146593 |
| mdprc 109 05 16 000 | Anspach Cos | OCM Cutting Burrs (Cutters) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144999 |
| mdprc 108 05 16 000 | Neusoft Medical System Co | NeuViz 64 Multi-Slice CT Scanner System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145070 |
| mdprc 107 05 16 000 | Medtronic Advanced Energy, LLC | Visualase Cooled Laser Applicator System (VCLAS) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146274 |
| mdprc 106 05 16 000 | Lumenis Inc | Lumenis M22 System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144941 |
| mdprc 105 05 16 000 | Diamedix Corporation | Diamedix Is-Mumps IgG Test Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144776 |
| mdprc 079 05 16 000 | Stryker Sustainability Solutions | Mallinckrodt Evac Tracheal Tubes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145078 |
| mdprc 078 05 16 000 | Siemens Healthcare Diagnostics GmbH | Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144211 |
| mdprc 077 05 16 000 | Covidien LLC | Covidien Kangaroo Connect Enteral Feeding Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144698 |
| mdprc 076 05 16 000 | Baxter Healthcare Corp | GEM Microvascular Anastomotic FlowCOUPLER Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145391 |
| mdprc 075 05 16 000 | Ascom | Ascom Mobile Monitoring Gateway | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144525 |
| mdprc 062 05 16 000 | RESEARCH INSTRUMENTS LTD | Integra 3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144524 |
| mdprc 061 05 16 000 | Siemens Medical Solutions | Syngo Dynamics; Kinetdx Picture Archiving and Communications System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145387 |
| mdprc 060 05 16 000 | Novarad Corporation | NovaPAC Diagnostic Viewer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145814 |
| mdprc 059 05 16 000 | Ferno-Washington Inc. | Poly-bags containing splint strap labeled with "Pediatric" sticker | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144677 |
| mdprc 058 05 16 000 | Atlas Spine | Atlas Spine Torque Limiting Handle 6N-m | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144672 |
| mdprc 040 05 16 000 | SIEMENS | MAGNETOM Aera/Skyra Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145542 |
| mdprc 039 05 16 000 | FUJIFILM Medical Systems | Power Supply Used with Smart CR Digital X-Ray Cassette Readers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144696 |
| mdprc 037 05 16 000 | bioMerieux Inc | VITEK 2 Gram Positive Susceptibility Test Cards | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144536 |
| mdprc 036 05 16 000 | Alcon Research, Ltd. | INFINITI Ultrasound Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144937 |
| mdprc 035 05 16 000 | Synthes GmbH | Periprosthetic Locking Screw Self-tapping 12 mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144953 |
| mdprc 034 05 16 000 | SIEMENS | ACUSON X700 Ultrasound System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145322 |
| mdprc 033 05 16 000 | Shimadzu Medical Systems. | X-Ray Diagnostic Table, Model No. YSF-300 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144860 |
| mdprc 032 05 16 000 | Philips Healthcare | NeuViz 16 Multi-Slice CT Scanner System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144838 |
| mdprc 031 05 16 000 | Mindray DS USA | Panorama Patient Monitoring Network. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144763 |
| mdprc 030 05 16 000 | LED Technologies, LLC | reVive Light Therapy Pain Relief Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144963 |
| mdprc 029 05 16 000 | JAS Diagnostics Inc. | D3 Hematology AnalyzerD3 Reagent Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144664 |
| mdprc 025 05 16 000 | Intuitive Surgical Inc | EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144835 |
| mdprc 024 05 16 000 | Hologic Inc | CF InPlex ASR Card | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144865 |
| mdprc 023 05 16 000 | Hardy Diagnostics | GBS Detect | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144758 |
| mdprc 022 05 16 000 | Becton Dickinson & Co. (BD) | BD Trucount Absolute Counting Tubes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144863 |
| mdprc 138 04 16 000 | WFR-Aquaplast/Q-Fix Systems | ClearVue Prone Breast Treatment Table | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144438 |
| mdprc 135 04 16 000 | Stryker | Spirit One A-C Powered Hospital Bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138676 |
| mdprc 134 04 16 000 | SIEMENS | Siemens SOMATOM Definition | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144615 |
| mdprc 133 04 16 000 | Siemens Healthcare Diagnostics | ADVIA 560 Hematology Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144542 |
| mdprc 132 04 16 000 | Philips Healthcare | eCareCoordinator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144720 |
| mdprc 131 04 16 000 | Mevion Medical Systems, Inc. | MEVION S250 for Proton Radiation Therapy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144555 |
| mdprc 130 04 16 000 | Hansen Medical, Inc. | Magellan Robotic Catheter Accessory Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144725 |
| mdprc 129 04 16 000 | Boston Scientific | Ultraflex Tracheobronchial Distal Release Stent System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144674 |
| mdprc 128 04 16 000 | Becton Dickinson & Co. (BD) | Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144969 |
| mdprc 126 04 16 000 | Baxter Healthcare | AMIA Automated Peritoneal Dialysis System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144203 |
| mdprc 078 04 16 000 | Merit Medical Systems Inc | Boston Scientific TSX Transseptal Needle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144636 |
| mdprc 077 04 16 000 | AD-TECH Medical Instrument Corporation | Ad-Tech Electrode Connection System/Cables | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144756 |
| mdprc 075 04 16 000 | ICU Medical, Inc | Diana Automated Compounding System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144403 |
| mdprc 074 04 16 000 | Natus Medical Inc | Medix NatalCare ST-LX Intensive Care Incubator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142443 |
| mdprc 073 04 16 000 | Us Endovascular | USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143315 |
| mdprc 048 04 16 000 | SIEMENS | Picture Archiving and Communication System , syngo Imaging. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144261 |
| mdprc 047 04 16 000 | Arthrex Inc | Arthrex Deltoid Ligament | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144510 |
| mdprc 046 04 16 000 | AngioDynamics Inc | NAMIC Convenience Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142590 |
| mdprc 045 04 16 000 | Therakos Inc A Johnson & Johnson Co | The THERAKOS CELLEX Photopheresis System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142725 |
| mdprc 044 04 16 000 | ScottCare Corp | Model TS01 TeleSentry Batteries | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143993 |
| mdprc 043 04 16 000 | Philips Electronics | evaluemed Infant Heel Warmer and eValueMed Infant Transport Mattresses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143732 |
| mdprc 042 04 16 000 | Innovative Ophthalmic Products, Inc | Molteno3 Glaucoma Implants G-Series | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144004 |
| mdprc 041 04 16 000 | Fresenius Medical Care | Hemoflow F3 Dialyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144015 |
| mdprc 040 04 16 000 | Cardinal Health | Gomco Style Circumcision Clamp Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144307 |
| mdprc 039 04 16 000 | Biomet Inc. | Prelude PF Resurfacing Knee System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144285 |
| mdprc 038 04 16 000 | Amd Ritmed | IMCO brand Conforming Stretch Gauze Bandages | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143875 |
| mdprc 037 04 16 000 | Implant Direct LLC | GoDirect Implants | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144215 |
| mdprc 036 04 16 000 | Medtronic Neuromodulation | Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144178 |
| mdprc 034 04 16 000 | SIEMENS | SOMATOM Emotion and Sensation Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144267 |
| mdprc 033 04 16 000 | SIEMENS | Artis zee/ zeego system, x-ray, angiographic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144445 |
| mdprc 032 04 16 000 | SIEMENS | CIOS ALPHA (Image-intensified fluoroscope x-ray system) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144441 |
| mdprc 031 04 16 000 | SIEMENS | Artis One, Interventional, Fluoroscopic, x-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144567 |
| mdprc 030 04 16 000 | SIEMENS | Cios Alpha, mobile X-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144566 |
| mdprc 027 04 16 000 | PMBS, LLC | The S.C.O.R.E.S. Unit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143282 |
| mdprc 026 04 16 000 | The Anspach Effort, Inc. | Irrigation Clip 30 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144160 |
| mdprc 025 04 16 000 | Neurotherm, Inc. | Neurotherm Curved Radiofrequency (RF) cannnula 10 cm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144148 |
| mdprc 024 04 16 000 | Cook Inc, | Ascend AQ and UltraxxTM Nephrostomy Balloon Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144044 |
| mdprc 023 04 16 000 | Biomet Inc | Vanguard XP Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144063 |
| mdprc 004 04 16 000 | Toshiba Medical Systems Corporation | DRAD-3000E FPD Wireless Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142948 |
| mdprc 003 04 16 000 | Sorin Group | HeaterCooler 3T | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143928 |
| mdprc 002 04 16 000 | Siemens Medical Solutions | Siemens Syngo Dynamics | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144270 |
| mdprc 001 04 16 000 | Arthrex Inc | iBalance TKA Tibial Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143925 |
| mdprc 152 03 16 000 | Carl Zeiss Meditec Inc | Surgical microscope and accessories, OPMI Pentero C | FDA |
| mdprc 146 03 16 000 | Nordisk Rontgen Teknik A/S | GE Precision MPi is an all-digital multipurpose tilt-C x-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141343 |
| mdprc 145 03 16 000 | Cook Inc, | Flexor Check-Flo Introducer | FDA |
| mdprc 140 03 16 000 | Value Plastics, Inc. | Custom FCFFM x/8.2 cm Tubing Extension | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142593 |
| mdprc 139 03 16 000 | TEM Innovations GmbH | ROTROL P Control for ROTEM delta Thromboelastometry System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143943 |
| mdprc 138 03 16 000 | Pro-Dex Inc | KLSBP001 Battery Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142867 |
| mdprc 137 03 16 000 | Medtronic Navigation, Inc. | The O-arm O2 Imaging System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143801 |
| mdprc 136 03 16 000 | Collagen Matrix Inc | NuOss XC Sinus | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143566 |
| mdprc 135 03 16 000 | Becton Dickinson & Co. (BD) | BD Intelliport Medication Management System Sensor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142710 |
| mdprc 134 03 16 000 | Bard Pcripheral Vascular (BPV) | Nordson Medical Stopcocks Used with Denali Inferior Vena Cava Filters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143978 |
| mdprc 133 03 16 000 | Zimmer inc. | M/L Taper Hip Prosthesis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143788 |
| mdprc 132 03 16 000 | Stryker | AccuPlace Needle Guides | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143589 |
| mdprc 131 03 16 000 | Novadaq Technologies Inc. | PINPOINT Endoscopic Fluorescence Imaging System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143596 |
| mdprc 130 03 16 000 | Medical Action Industries Inc | Tegaderm PICC/CVC dressing change convenience kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143609 |
| mdprc 129 03 16 000 | Gi Supply | Large Volume Paracentesis Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143218 |
| mdprc 128 03 16 000 | Bigwall Enterprises | Warm Steam Personal Steam Inhaler | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142338 |
| mdprc 127 03 16 000 | Cooper Surgical, Inc. | Milex Arcing Diaphragm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143902 |
| mdprc 126 03 16 000 | Aesculap | Columbus Revision Knee System, EnduRo Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142358 |
| mdprc 125 03 16 000 | Xeridiem Mediem Medical Devices Inc | EndoVive 3s Low Profile Balloon | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142778 |
| mdprc 124 03 16 000 | Teleflex Medical | WECK AutoEndo5 Hem-o-lok 5 mm Automatic Endoscopic Hem-o-lok Appliers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143353 |
| mdprc 123 03 16 000 | SIEMENS | Mammomat Inspiration with Tomosynthesis functionality | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143817 |
| mdprc 122 03 16 000 | Karman Healthcare Inc. | Karma Flexx Wheelchair | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143292 |
| mdprc 121 03 16 000 | Ivoclar Vivadent AG | Helioseal Clear Refill | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143819 |
| mdprc 120 03 16 000 | Integrated Medical Systems Inc | Olympus endoscope | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143143 |
| mdprc 119 03 16 000 | Fresenius Kabi Ltd | Fresenius Naturalyte Liquid Acid Concentrate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143014 |
| mdprc 005 01 16 001 | Draeger Medical Systems Inc | Evita V500 Ventilator and Babylog VN500 Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143615 |
| mdprc 118 03 16 000 | Cook Inc, | Kopans Breast Lesion Localization Needles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143030 |
| mdprc 117 03 16 000 | Biomet Inc. | HipLOC CHS Plate/Lag Screw Introducer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143636 |
| mdprc 093 03 16 000 | Stryker Howmedica Osteonics Corp | Stryker Vitallium Wire (6 Pack) Non Sterile. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142877 |
| mdprc 092 03 16 000 | SIEMENS | Syngo Plaza Picture archiving and communication system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142876 |
| mdprc 091 03 16 000 | Hospira Inc. | Symbiq Infusion Pump System Pole Clamp Assemblies | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143072 |
| mdprc 090 03 16 000 | Hill Rom | Bariatric Power Recliner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143155 |
| mdprc 089 03 16 000 | EKOS Corp | EkoSonic Endovascular System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143565 |
| mdprc 083 03 16 000 | Centurion Medical Products | Centurion Convenience Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143304 |
| mdprc 081 03 16 000 | Sorin | Dual Stage Venous Return Catheter. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143595 |
| mdprc 080 03 16 000 | Smith & Nephew | High Flow Irrigation Extender | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142484 |
| mdprc 079 03 16 000 | Olympus | DELTA XRF analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143625 |
| mdprc 078 03 16 000 | Bio Rad | EVOLIS Microplate System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142855 |
| mdprc 050 03 16 000 | Viewray Incorporated | MRIdian ViewRay Radiation Therapy System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143035 |
| mdprc 049 03 16 000 | Pharmacaribe llc | PulmoSal | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142921 |
| mdprc 048 03 16 000 | Orthofix | Firebird Spinal Fixation System Torque Limiting Handle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142988 |
| mdprc 047 03 16 000 | Moog Medical Devices Group Inc | Curlin and Painsmart Ambulatory Volumetric Infusion Pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142508 |
| mdprc 046 03 16 000 | Zimmer inc | Zimmer IMPLANT,TM, MTX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142734 |
| mdprc 045 03 16 000 | Toshiba Medical Systems | INFX-8000V Bi-Plane | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143016 |
| mdprc 044 03 16 000 | Salter Labs | T-piece Nebulizer with in-line connectors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143122 |
| mdprc 041 03 16 000 | Mizuho | Mizuho OSI Trios, Table Base | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142535 |
| mdprc 080 02 16 000 | Siemens Healthcare Diagnostics GmbH | Multiple acute care kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141547 |
| mdprc 079 02 16 000 | Trumpf Medical Systems, Inc. | Jupiter, Mars, Titan, TruSystem and Saturn operating table systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143071 |
| mdprc 078 02 16 000 | Spectranetics Corporation | 2.3mm Turbo-Power OTW | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143064 |
| mdprc 077 02 16 000 | Philips Medical Systems | The Pinnacle3 Radiation Therapy Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142775 |
| mdprc 076 02 16 000 | Del Medical, Inc. | VS300 and VS200 radiographic Cassette Holder or Wall Stand | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142237 |
| mdprc 075 02 16 000 | Bard Pcripheral Vascular (BPV) | Bard Distaflo Vascular Bypass Graft | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142774 |
| mdprc 055 02 16 000 | Radiometer Medical | AQURE System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142591 |
| mdprc 054 02 16 000 | Global Healthcare Inc. | ET-20 Anesthesia Extension Tubes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142907 |
| mdprc 036 02 16 000 | Instrumentation Laboratory | HemosIL Plasminogen | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142610 |
| mdprc 035 02 16 000 | HORIBA ABX Diagnostics | ABX PENTRA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142858 |
| mdprc 034 02 16 000 | Baxter Healthcare | RAPIDFILL Syringe Strip. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142564 |
| mdprc 033 02 16 000 | Bard Pcripheral Vascular (BPV) | Bard Denali IVC Filter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142563 |
| mdprc 100 01 16 000 | Siemens Medical Solutions | E.cam Dual Signature; Gamma Camera | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142872 |
| mdprc 099 01 16 000 | Rymed Technologies, LLC | InVision-Plus, InVision-Plus and InVision-Plus CS Needleless IV Connector | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142692 |
| mdprc 077 01 16 000 | MAQUET Inc | Servo-I ventilator system CO2 analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132596 |
| mdprc 076 01 16 000 | Zimmer inc | Periarticular Locking Plate System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142544 |
| mdprc 075 01 16 000 | Biomet Inc | Biomet Integral Centralizer Hip System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141358 |
| mdprc 074 01 16 000 | Beckman Coulter Inc | iChem 10 SG Urine Chemistry Strips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142510 |
| mdprc 070 01 16 000 | Thornhill Research Inc | MOVES System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142381 |
| mdprc 069 01 16 000 | Stryker | Reprocessed Stryker Color Cuff and Color Cuff II | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142400 |
| mdprc 068 01 16 000 | Perkinelmer | WIZARD2 Automatic Gamma Counter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142254 |
| mdprc 067 01 16 000 | Mercury Medical | Neo-Tee T-Piece Resuscitator and T-Piece Circuit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141479 |
| mdprc 061 01 16 000 | OrthoPediatrics Corp | UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142594 |
| mdprc 060 01 16 000 | Nipro Medical Corporation | NIPRO SET / SLIMLINE BLOOD TUBING SET | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142001 |
| mdprc 047 01 16 000 | Ultradent Products, Inc | InterGuard 5.5mm Econo Refill | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142285 |
| mdprc 046 01 16 000 | Steris Corp | AMSCO® Warming Cabinet | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142305 |
| mdprc 045 01 16 000 | Philips | Philips Lumify Diagnostic Ultrasound | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142399 |
| mdprc 044 01 16 000 | Benlan, Inc. | MED-RX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142354 |
| mdprc 041 01 16 000 | Vidco, Inc. | Remote Patient Monitoring System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142223 |
| mdprc 040 01 16 000 | Stryker Sustainability Solutions | Resterilized Fuhrman Pleural/Pneumopericardial Drainage Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142020 |
| mdprc 039 01 16 000 | Smith & Nephew | GENESIS II/LEGION Resurfacing Patella with JOURNEY Peg | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142377 |
| mdprc 038 01 16 000 | Corflex | Contender Post-op-Knee Brace Lite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142040 |
| mdprc 037 01 16 000 | CNSystems | CNSystems TASK FORCE MONITOR 3040i | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142016 |
| mdprc 011 01 16 000 | Biomet 3i Inc | ART 1036 Radiographic Transparency | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141861 |
| mdprc 010 01 16 000 | Becton Dickinson & Co. (BD) | Vacutainer K2EDTA Plus Plastic Blood Collection Tubes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142383 |
| mdprc 009 01 16 000 | Rainbow Specialty & Health Products | Dressit-X | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142039 |
| mdprc 008 01 16 000 | Philips Healthcare | Cardinal Health Tiny Toes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141972 |
| mdprc 007 01 16 000 | Merge Healthcare Corp. | Merge Hemo and Merge Cardio | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141901 |
| mdprc 006 01 16 000 | Hardy Diagnostics | FB Broth | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142209 |
| mdprc 004 01 16 000 | DePuy International Ltd | VAPR TRIPOLAR 90" Degree Suction Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142122 |
| mdprc 003 01 16 000 | Biomet Inc | Green and Black Mamba Suture Passer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142310 |
| mdprc 002 01 16 000 | Arthrosurface, Inc. | Total Toe Instrument Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141991 |
| mdprc 001 01 16 000 | Airways Development LLC | WaterPAP Positive Airway Pressure Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142352 |
| mdprc 113 12 15 000 | Zimmer inc | Zimmer Oscillating Flat | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142288 |
| mdprc 108 12 15 000 | SIEMENS | SOMATOM Definition | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142157 |
| mdprc 107 12 15 000 | Instratek Incorporated | Endoscopic Tarsal Tunnel Decompression | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142098 |
| mdprc 106 12 15 000 | DePuy Spine, Inc | Aegis Torque Handle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141825 |
| mdprc 105 12 15 000 | CareFusion 303, Inc. | Alaris EtCO2 Modules | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141712 |
| mdprc 100 12 15 000 | Edwards Lifesciences | Intravascular (IV) Administration Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141985 |
| mdprc 099 12 15 000 | Myco Medical Supplies | Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141671 |
| mdprc 098 12 15 000 | Remel | Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141388 |
| mdprc 097 12 15 000 | Summit Medical, Inc. | AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140459 |
| mdprc 093 12 15 000 | Verathon Inc | GlideScope Video GVL and AVL Laryngoscope Blades | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141766 |
| mdprc 092 12 15 000 | Teleflex Medical | Hudson RCI Heated Ventilator Circuits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142044 |
| mdprc 091 12 15 000 | Stryker Communications | Stryker Cournand Modified 2PC 19 gauge, 5.4 centimeter guidewire introducer needles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142281 |
| mdprc 090 12 15 000 | Moog Medical Devices Group Inc | EnteraLite Infinity Enteral Pumps and Administration Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141973 |
| mdprc 089 12 15 000 | K-jump Health Co Ltd | K-Jump Digital Temple Thermometers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141980 |
| mdprc 088 12 15 000 | FUJIFILM Medical Systems | Dudenoscope | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140362 |
| mdprc 073 12 15 000 | Philips Healthcare | Brilliance CT (computed tomography) scanners, Big Bore configuration | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129680 |
| mdprc 072 12 15 000 | Philips Healthcare | The eCareManager system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135619 |
| mdprc 071 12 15 000 | Boston Scientific | One Step Button, Low Profile Initial Placement PEG Kit. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140781 |
| mdprc 070 12 15 000 | Draeger Medical Inc | Perseus A500 Anesthesia Workstation, MK06000. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141791 |
| mdprc 069 12 15 000 | Philips Healthcare | Philips Healthcare Brilliance 64, Ingenuity Core, Ingenuity Core 128 and Ingenuity CT Computed Tomography X-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139378 |
| mdprc 043 12 15 000 | Intuitive Surgical Inc | Telemanipulation Systems, Surgical, Minimally Invasive, daVinci | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117854 |
| mdprc 028 12 15 000 | WalkMed Infusion, LLC | Triton fp Infusion Pump (model 400000) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141640 |
| mdprc 027 12 15 000 | Merz pharmceuticals | PROLARYN Gel and PROLARYN PLUS Injectable Implants | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141619 |
| mdprc 020 12 15 000 | DeRoyal Industries Inc. | HYDRO-TEMP® | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141078 |
| mdprc 019 12 15 000 | DeRoyal Industries Inc. | Various DeRoyal Surgical Kits. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141577 |
| mdprc 117 11 15 000 | Alcon Research, Ltd | AcrySof IQ Toric IOL | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140828 |
| mdprc 114 11 15 000 | Philips Medical Systems | Ingenia, Intera, Achieva and Achieve dStream | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129687 |
| mdprc 113 11 15 000 | Leonhard Lang GmbH | ECG Electrodes 50007 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141578 |
| mdprc 099 11 15 000 | Teleflex Medical | PI-93 Taut Intraducer Peritoneal Catheters with Martech Hemo Valve Flat Caps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140988 |
| mdprc 098 11 15 000 | Cyberonics Inc | Cyberonics VNS Therapy AspireSR Generator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140876 |
| mdprc 097 11 15 000 | Civco Medical Instruments Inc | Infiniti Plus kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140835 |
| mdprc 096 11 15 000 | Astora | MiniArc Pro | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141509 |
| mdprc 095 11 15 000 | AGFA Corp. | IMPAX Cardiovascular IMPAX CV12 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140966 |
| mdprc 083 11 15 000 | Precision Medical. | Easy Dial Oxygen Regulator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141042 |
| mdprc 082 11 15 000 | Medtronic | Perfusion Tubing Packs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141501 |
| mdprc 081 11 15 000 | Instrumentation Industries Inc | Cuffed Ventilator Tubing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140927 |
| mdprc 073 11 15 000 | Ceterix Orthopedics, Inc. | NovoCut Suture Manager | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141289 |
| mdprc 061 11 15 000 | Villa Radiology Systems LLC. | Villa Sistemi Rotograph EVO and Owandy Radiology I -MAX Touch 3D X-ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139450 |
| mdprc 060 11 15 000 | Utah Medical Products, Inc | Myelo-Nate CSF Sampling Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141130 |
| mdprc 059 11 15 000 | Resource Optimization & Innovation Llc | Regard Custom Surgical Pack.. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139676 |
| mdprc 058 11 15 000 | Miramar Labs, Inc. | miraDry System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140877 |
| mdprc 057 11 15 000 | DeRoyal Industries Inc. | DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139865 |
| mdprc 056 11 15 000 | CareFusion 303, Inc | SmartSite Extension Sets. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140871 |
| mdprc 055 11 15 000 | Stryker Spine | UniVise Spinous Process Fixation Plate System Inserter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141264 |
| mdprc 054 11 15 000 | Ivoclar Vivadent | Helioseal F Sealant Refill 1 x 1.25 g | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140485 |
| mdprc 053 11 15 000 | ELITech Clinical Systems SAS | Envoy 500 , Eon 100, Eon 300 and Selectra ProS and ProM systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140619 |
| mdprc 052 11 15 000 | Bausch & Lomb Inc. | BAUSCH + LOMB Biotrue(R) ONEday lenses (nesofilcon A) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140144 |
| mdprc 051 11 15 000 | Arrow International Inc | PICC Kits with GLIDETHRU Components | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141136 |
| mdprc 035 11 15 000 | Medtronic | Medtronic Achieve Cables | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139896 |
| mdprc 034 11 15 000 | Biomet Inc | MaxAn 4.0mm and 4.5mm fixed screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140568 |
| mdprc 024 11 15 000 | Synthes Inc | Synthes Threaded Plate Holder Long for 3.5mm Locking Hold | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140745 |
| mdprc 023 11 15 000 | Integra LifeSciences | Integra® Bone Marrow Biopsy Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140452 |
| mdprc 021 11 15 000 | Baxter Healthcare | Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140768 |
| mdprc 002 11 15 000 | Perkin Elmer Life Sciences Inc | Perkin Elmer Specimen Gate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139579 |
| mdprc 001 11 15 000 | Encore Medical, Lp | Exprt Precision System: Revision Knee | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140223 |
| mdprc 111 10 15 000 | Stryker | TELETOM Series 4 and 6 Booms | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140448 |
| mdprc 110 10 15 000 | Materialise N.V | The Signature Personalized Patient Care System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141084 |
| mdprc 109 10 15 000 | Biomet Inc | Thinflap System Case and Neuro Combo Set Case | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140801 |
| mdprc 108 10 15 000 | B Braun Medical Inc | Perifix Continous Epidural Anesthesia Pain Control Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140317 |
| mdprc 100 10 15 000 | Synthes Inc | 5.0mm Unit Stainless Steel Rods for the Synthes Small Stature USS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139928 |
| mdprc 099 10 15 000 | Cardinal-Health | Ambitex NMD400 Nitrile Exam Gloves | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140214 |
| mdprc 098 10 15 000 | Encore Medical, Lp | AltiVate Humeral Socket Shell Trial | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140188 |
| mdprc 090 10 15 000 | Synthes Inc | Synthes Screw Inserter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140322 |
| mdprc 089 10 15 000 | Synthes Inc | 2.7 mm/3.5 mm VA-LCP Medial Distal Plates | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140637 |
| mdprc 088 10 15 000 | DJO LC | Monode , Shortwave Accessory | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140080 |
| mdprc 068 10 15 000 | Natus Medical Inc | NicoletOne Software v5.94 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139574 |
| mdprc 067 10 15 000 | Medtronic Inc | Pipeline and Pipeline Flex Embolization Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140075 |
| mdprc 050 10 15 000 | Concentric Medical Inc | Distal Access Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140343 |
| mdprc 049 10 15 000 | Viewray Incorporated | MRIdian® ViewRay® Radiation Therapy System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140076 |
| mdprc 048 10 15 000 | SIEMENS | SOMATOM Force | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139933 |
| mdprc 043 10 15 000 | Beckman Coulter, Inc.. | MICroSTREP plus 1 and MICroSTREP plus 2 Panels | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140096 |
| mdprc 042 10 15 000 | Toshiba Medical Systems Corporation | Toshiba Celesteion PCA-9000A/2 PET/CT System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138996 |
| mdprc 041 10 15 000 | Resource Optimization & Innovation Llc | Multiple surgical kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139308 |
| mdprc 040 10 15 000 | Zimmer inc | Zimmer Universal Locking System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139904 |
| mdprc 039 10 15 000 | Ortho Solutions | UltOS Locking Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139303 |
| mdprc 037 10 15 000 | Integra LifeSciences | Universal Compact Head Ring Adapter Plate (UCHRAP) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139703 |
| mdprc 036 10 15 000 | Synthes Inc | Periarticular Insertion Handle and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140316 |
| mdprc 025 10 15 000 | Ferno-Washington Inc | Ferno iNX Wheeled Stretcher | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139518 |
| mdprc 024 10 15 000 | Biosense Webster Inc | SOUNDSTAR eco 8F and 10F | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140078 |
| mdprc 016 10 15 000 | Lifeline Systems, Incorporated | Philips GoSafe Mobile Help Button; 7000MHB | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139235 |
| mdprc 007 10 15 000 | Arrow International Inc | Kits Containing Medtronic Covidien 0.9% Sodium Chloride Flush Syringes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139778 |
| mdprc 136 09 15 000 | STERILMED, INC | Reprocessed Zimmer Tourniquet Cuffs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139625 |
| mdprc 126 09 15 000 | Synthes Inc | Cranial Flap Tube Clamp and Crimping Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139935 |
| mdprc 111 09 15 000 | Resource Optimization & Innovation Llc | Regard ™ | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139600 |
| mdprc 097 09 15 000 | Terumo Cardiovascular Systems Corporation | Terumo Custom Cardiovascular Procedure Kit X-Coated. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139621 |
| mdprc 096 09 15 000 | Ecolab Inc | ORS Fluid Warming and Slush Drapes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139446 |
| mdprc 094 09 15 000 | SynCardia Systems Inc | Temporary Total Artificial Heart (TAH-t) with Freedom Driver System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139311 |
| mdprc 093 09 15 000 | Intuitive Surgical Inc | Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140020 |
| mdprc 092 09 15 000 | Edwards Lifesciences | Pressure Monitoring Kits and Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139472 |
| mdprc 091 09 15 000 | Lumenis Inc | Lumenis—VersaCut+ Tissue Morcellator Handpieces | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139255 |
| mdprc 083 09 15 000 | Nico Corp | NICO Myriad Console | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139582 |
| mdprc 082 09 15 000 | Applied Medical Resources | Voyant Open Fusion Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139445 |
| mdprc 081 09 15 000 | Med Tec Inc | CIVCO Shoulder Retractors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139409 |
| mdprc 072 09 15 000 | Revmedx Inc | XGAUZE Trauma Dressing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139586 |
| mdprc 071 09 15 000 | Biomet 3i Inc | UCLA Abutment Hexed Castable Cylinder 3.4mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139565 |
| mdprc 070 09 15 000 | Intuitive Surgical Inc | Da Vinci Si Single-Site Gripping Instruments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139635 |
| mdprc 069 09 15 000 | Terumo Cardiovascular Systems Corporation | CDI 500 Blood Parameter Monitoring System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139412 |
| mdprc 068 09 15 000 | Biomet Inc | 4 0 MM X 14 MM Variable Screw CTek Maxan Anterior Cervical Plate System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139414 |
| mdprc 061 09 15 000 | Wright Medical Technology, Inc. | CrossCHECK™ | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139287 |
| mdprc 060 09 15 000 | SIEMENS | Syngo.plaza;picture archiving and communications system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139480 |
| mdprc 059 09 15 000 | Roche Diagnostics Corp | cobas® Liat Analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139100 |
| mdprc 058 09 15 000 | Panoramic Rental Corp. | PC-1000 Panoramic X-Ray Machines | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138586 |
| mdprc 057 09 15 000 | Mindray DS USA, Inc. | DPM 7 Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139403 |
| mdprc 056 09 15 000 | Medtronic | MEDTRONIC PERFUSION TUBING PACKS and MEDIVATORS HEMOCOR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139597 |
| mdprc 055 09 15 000 | Limacorporate | Trial Adaptor Head | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139473 |
| mdprc 054 09 15 000 | Covidien LLC | Covidien Monoject 0.9% Saline Flush Syringes and Prefill Double Pouches | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139418 |
| mdprc 053 09 15 000 | C.R. Bard, Inc. | Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139591 |
| mdprc 032 09 15 000 | Trilliant Surgical Ltd | 7, 9, & 11Hole VL Gridlock Fibula Plating System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139466 |
| mdprc 030 09 15 000 | Arrow International Inc | PICC Kits and VPS Access Kits with Touhy Borst Component | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139228 |
| mdprc 029 09 15 000 | Pointe Scientific Inc | G6PD Screening Controls | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139536 |
| mdprc 028 09 15 000 | Biomet Inc | Vision RingLoc Acetabular System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139224 |
| mdprc 027 09 15 000 | Trilliant Surgical Ltd | Tiger Cannulated Tray Lid | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139142 |
| mdprc 026 09 15 000 | Tornier Inc | Salto Talaris Tibial Guide | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139327 |
| mdprc 025 09 15 000 | Synthes Inc | Synthes Application Instrument for Sternal ZIPFIX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139179 |
| mdprc 024 09 15 000 | Sunrise Medical | Zippie IRIS and Quickie IRIS Wheelchairs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139171 |
| mdprc 023 09 15 000 | Stryker | Reprocessed Ethicon ExcelTrocar Sleeve | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139129 |
| mdprc 022 09 15 000 | Nidek Co. Ltd. | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138756 |
| mdprc 021 09 15 000 | Hardy Diagnostics | HardyCHROM MRSA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139127 |
| mdprc 010 06 14 001 | Physio Control Inc | LIFEPAK 1000 Defibrillators | Swissmedic |
| mdprc 211 08 15 000 | RaySearch Laboratories | RayStation 4.7 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137704 |
| mdprc 208 08 15 000 | The Anspach Effort, Inc. | Synthes Battery Power Line II Oscillator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138616 |
| mdprc 207 08 15 000 | Symmetry Surgical | Disposable Towel Clamps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137258 |
| mdprc 206 08 15 000 | Sedecal S.A | RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138818 |
| mdprc 205 08 15 000 | Medtronic Navigation Inc | Medtronic Passive Biopsy Needle Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138971 |
| mdprc 204 08 15 000 | GE Healthcare | GE Optional Laser Centering Device X-ray generator. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131702 |
| mdprc 141 06 15 001 | Fresenius Medical Care | Fresenius NaturaLyte Bicarbonate Concentrate Bottles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136307 |
| mdprc 203 08 15 000 | CareFusion 303, Inc | Alaris Syringe Pump, Model No. 8110 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138585 |
| mdprc 202 08 15 000 | C.R. Bard, Inc. | Magic3 Hydrophiliccoated Female Intermittent Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138833 |
| mdprc 201 08 15 000 | B Braun | Celsite Implantable Access Port System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138664 |
| mdprc 200 08 15 000 | American Science & Engineering, Inc. | Gemini Cabinet Xray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138765 |
| mdprc 199 08 15 000 | Advanced Sterilization Products | Wall Chart for STERRAD 100NX System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138474 |
| mdprc 198 08 15 000 | The Anspach Effort, Inc. | Synthes Battery Power Line II Oscillator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138616 |
| mdprc 197 08 15 000 | Trilliant Surgical Ltd | Concave Reamer Head, Cannulated Drill Bit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139145 |
| mdprc 196 08 15 000 | Synthes Inc | Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138815 |
| mdprc 195 08 15 000 | SIEMENS | Siemens Symbia T Series, Siemens Intevo Series system, Siemens Symbia S Series system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139260 |
| mdprc 194 08 15 000 | Otto Bock Healthcare Products GmbH | Genium X3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139437 |
| mdprc 193 08 15 000 | Elite Biomedical Solutions | Alaris Medley Large Volume Pump Frame Membranes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138352 |
| mdprc 192 08 15 000 | Covidien LLC | Covidien Argyle Infant Heel Warmers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139096 |
| mdprc 189 08 15 000 | Zimmer inc | Dual Port/Single Bladder Disposable Tourniquet Cuff | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138728 |
| mdprc 188 08 15 000 | Roche Diagnostics Corp | S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138377 |
| mdprc 187 08 15 000 | Invacare Corporation | Invacare Pronto Air Personal Transporter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138406 |
| mdprc 186 08 15 000 | Atrium Medical Corporation | Atrium 36Fr Right Angled Firm PVC Thoracic Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138023 |
| mdprc 153 08 15 000 | Synthes Inc | Titanium Matrix Pre-bent Maxillary Plates | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138328 |
| mdprc 152 08 15 000 | Skeletal Kinetics, Llc | InjectionPlasty 1.0 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137879 |
| mdprc 151 08 15 000 | Otto Bock Healthcare Products GmbH | Ottobock Pheon 3R62 Knee Joint | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138816 |
| mdprc 150 08 15 000 | McKesson Technologies, Inc | Paragon Laboratory Management | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138221 |
| mdprc 149 08 15 000 | Encore Medical, Lp | Femoral Cut Block | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138622 |
| mdprc 122 08 15 000 | Myoscience Inc | iovera 155 Smart Tip | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138539 |
| mdprc 121 08 15 000 | EKOS Corp | EKOS EkoSonic Endovascular System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138434 |
| mdprc 120 08 15 000 | Cochlear AG | Cochlear Nucleus Sterile Silicone Template | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138017 |
| mdprc 119 08 15 000 | Abbott Laboratories | ARCHITECT c8000 System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137918 |
| mdprc 097 05 15 001 | GE Healthcare | CT LightSpeed 16 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136320 |
| mdprc 109 08 15 000 | Stryker Communications | Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138120 |
| mdprc 108 08 15 000 | Allergan services international Limited | Natrelle 133 Series Tissue Expanders | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137972 |
| mdprc 011 08 15 000 | Synthes Inc | TFNA Helical-Blade Impactor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137950 |
| mdprc 010 08 15 000 | Stryker Instruments | Neptune 2 Waste Management System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137933 |
| mdprc 009 08 15 000 | Cooper Surgical, Inc. | Milex Vaginal-Hymenal Silicone Dilators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138256 |
| mdprc 008 08 15 000 | Alere | Alere i flu, Alere i, Alere Influenza A & B | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138289 |
| mdprc 007 08 15 000 | Zimmer inc | ZNN Antegrade Femoral Nail (ZNN AF) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138114 |
| mdprc 006 08 15 000 | Stryker | Stryker Woundcare Tubing Replacement Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137181 |
| mdprc 005 08 15 000 | OMNIlife science | Apex ARC Hip Stem | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137697 |
| mdprc 004 08 15 000 | Integra LifeSciences | Integra Long Epidural Steroid Injection Needle (Tuohy Needle). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136261 |
| mdprc 003 08 15 000 | Exactech | Exactech Ambassador Cervical Plate System and Exactech Single Barrel Drill Guides | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138003 |
| mdprc 002 08 15 000 | Exactech | Exactech Spine, Large Set Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138110 |
| mdprc 001 08 15 000 | Biomet Inc | A.L.P.S., Distal Tibia Plating System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138179 |
| mdprc 058 07 15 000 | Synthes Inc | TITANIUM END CAP WITH T40 STARDRIVE RECESS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137807 |
| mdprc 057 07 15 000 | Maquet Cardiovascular | Suspension Arms Used With PowerLED, Volista, and X-TEN Surgical Light Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137391 |
| mdprc 056 07 15 000 | Biomet Inc | A.L.P.S. Foot Locking Calcaneus Plate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138025 |
| mdprc 055 07 15 000 | Allergan Inc | Natrelle Re-sterilizable Breast Implant Sizer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137741 |
| mdprc 035 07 15 000 | SIEMENS | ACUSON SC2000 Ultrasound Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137900 |
| mdprc 034 07 15 000 | SIEMENS | SYNGO IMAGING | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138013 |
| mdprc 091 09 14 001 | Justright Surgical, LLC | JustRight 5mm Reload | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129735 |
| mdprc 029 07 15 000 | SIEMENS | SOMATOM Emotion 6 & SOMATOM Emotion 16 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138061 |
| mdprc 028 07 15 000 | Sechrist Industries Inc | Sechrist Low Profile Wheeled Stretcher | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137869 |
| mdprc 027 07 15 000 | Ortho-Clinical Diagnostics | VITROS 5,1 FS Chemistry System, VITROS 5,1 Refurbished, VITROS 4600 and 5600 Chemistry System.. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119029 |
| mdprc 026 07 15 000 | New Star Lasers, Inc. | StoneLight 30 Laser System (NS3000) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137356 |
| mdprc 025 07 15 000 | LifeHealth, LLC | IRMA TRUPOINT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137245 |
| mdprc 024 07 15 000 | Biomet Inc | Gentle Threads Interference Screw 9x35mm Full Thread | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138106 |
| mdprc 023 07 15 000 | Atrium Medical Corporation | A.Oasis Drain, Dry Single W/AC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135861 |
| mdprc 022 07 15 000 | RTI Surgical, Inc | Bullet-Tip PEEKVBR/IBF System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137744 |
| mdprc 021 07 15 000 | Pega Medical | SCFE Drivers of the FreeGliding SCFE Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138189 |
| mdprc 012 07 15 000 | Teleflex Medical | Hudson RCI LIFESAVER Neonate Manual Resuscitators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137056 |
| mdprc 011 07 15 000 | Cook Medical | LapSac Surgical Tissue Pouches | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137267 |
| mdprc 010 07 15 000 | Stryker | SERFAS 90 degree Energy Probe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137610 |
| mdprc 149 06 15 000 | Terumo Cardiovascular Systems | Custom Cardiovascular Procedure Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136456 |
| mdprc 148 06 15 000 | X Spine Systems Inc | Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137421 |
| mdprc 147 06 15 000 | Merit Medical Systems Inc | Prelude Sheath Introducers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138060 |
| mdprc 140 06 15 000 | Cooper Surgical, Inc. | McKesson Medi-Pak Vaginal Speculum | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137298 |
| mdprc 118 06 15 000 | Biomet Inc | Construx Alum Ankle Clamp | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137058 |
| mdprc 117 06 15 000 | Medtronic | Medtronic Passive Planar Blunt Probe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137215 |
| mdprc 116 06 15 000 | Mortara Instrument, Inc. | ELI 380 Electrocardiograph | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137689 |
| mdprc 115 06 15 000 | Smith & Nephew Orthopaedic | REFLECTION 3 Acetabular System-Constrained Acetabular Liner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137316 |
| mdprc 114 06 15 000 | Orthofix | Firebird Spinal Fixation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137255 |
| mdprc 113 06 15 000 | Teleflex Medical | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137034 |
| mdprc 112 06 15 000 | Stryker Instruments | Navigation Systems-II Carts and Articulated Arm Cameras | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137176 |
| mdprc 111 06 15 000 | Siemens Healthcare Diagnostics GmbH | EasyLink(TM) Informatics System included with the Dimension Vista System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110905 |
| mdprc 110 06 15 000 | Neusoft Medical System Co | Neusoft NeuViz 64 Multi-slice | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137271 |
| mdprc 065 06 15 001 | MRP, LLC dba AMUSA | 0.9 Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135755 |
| mdprc 109 06 15 000 | DePuySynthes | Pull Reduction Devices for 4.3 mm Percutaneous Drill Guides | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137453 |
| mdprc 108 06 15 000 | CareFusion | Alaris PC unit model 8015 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136048 |
| mdprc 092 06 15 000 | Zimmer inc | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137182 |
| mdprc 091 06 15 000 | Vilex In Tennessee Inc | Vilex, Inc., FUZE 10.0 mm x 150 mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137355 |
| mdprc 090 06 15 000 | Cooper Surgical, Inc. | Ally Uterine Positioning System (Ally UPS) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137273 |
| mdprc 089 06 15 000 | Alcon Research, Ltd | The Alcon Custom Pak | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136291 |
| mdprc 088 06 15 000 | Advanced Sterilization Products | Tyvek Pouch/Roll with STERRAD Chemical Indicator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132564 |
| mdprc 067 06 15 000 | Advanced Back Technologies, Inc. | Extentrac Elite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135953 |
| mdprc 066 06 15 000 | Roscoe Medical Inc | NEBROS, Roscoe Mini Neb Compressor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136146 |
| mdprc 063 06 15 000 | Synthes, Inc. | Cannulated Drill Bits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137214 |
| mdprc 041 06 15 000 | Zimmer inc | Tibial Alignment Guide | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137123 |
| mdprc 040 06 15 000 | SIEMENS | Syngo.via and Syngo.x | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137299 |
| mdprc 039 06 15 000 | Smiths Medical, Inc | BCI Advisor Vital Signs Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134714 |
| mdprc 038 06 15 000 | Philips Medical Systems | Ingenuity TF PET/MR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136871 |
| mdprc 037 06 15 000 | Philips Medical Systems | Brilliance iCT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136899 |
| mdprc 036 06 15 000 | Bayer Healthcare LLC… | MEDRAD Stellant CT Injector System with Certegra | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137254 |
| mdprc 029 06 15 000 | Coreva Health Science LLC | ActCel Topical Hemostatic Dressing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137216 |
| mdprc 006 06 15 000 | Stryker Instruments | EliteCore FullCore Biopsy devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136466 |
| mdprc 005 06 15 000 | DePuy Spine, Inc | EXPEDIUM Spine System/Synapse System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135980 |
| mdprc 004 06 15 000 | Alere International Limited | Alere i Influenza A & B | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135960 |
| mdprc 132 05 15 000 | Ethicon Endo Surgery Inc | ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136653 |
| mdprc 131 05 15 000 | Richard-Allan Scientific | Lerner Laboratories Mucolexx, Mucolytic Agent 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136396 |
| mdprc 130 05 15 000 | DeRoyal Industries Inc | DeRoyal Medium Specimen Retrieval Bag, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136431 |
| mdprc 129 05 15 000 | CooperSurgical Inc | Model CTI-1015P 15 mm Suture Guide Used with Carter Thomason II Port Closure Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134970 |
| mdprc 128 05 15 000 | Philips Healthcare | Philips Healthcare DigitalDiagnost and DuraDiagnost Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135515 |
| mdprc 127 05 15 000 | Philips Healthcare | EPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology option | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136136 |
| mdprc 126 05 15 000 | Stryker Orthopaedics | Triathlon Femoral, Scorpio Femoral, Restoration Wedge Augments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135835 |
| mdprc 125 05 15 000 | Siemens Medical Solutions | SIEMENS Axiom Luminos dRF Max | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137251
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137253 |
| mdprc 124 05 15 000 | United Surgical Associates. | iGO, Elastic Ankle Support. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137082
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137085
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137088 |
| mdprc 123 05 15 000 | Siemens Medical Solutions | SOMATOM Perspective, SOMATOM Emotion 16, SOMATOM Emotion 6 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136101
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137249
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137248 |
| mdprc 102 05 15 000 | Stryker Howmedica Osteonics Corp | Kinemax Stem Extenders, 80 mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134666 |
| mdprc 101 05 15 000 | HeartWare Inc | HeartWare Ventricular Assist System (HVAD) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136083 |
| mdprc 100 05 15 000 | Handicare GmbH | ReTurn belt | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135822 |
| mdprc 099 05 15 000 | FUJIFILM Medical Systems | FujiMedical Synapse® Cardiovascular I ProSolv® CardioVascular | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135415 |
| mdprc 098 05 15 000 | Wright Medical Technology, Inc. | PHALINX (TM) HAMMER TOE HANDLE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136234
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136235
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136231 |
| mdprc 096 05 15 000 | Baxter Healthcare | ABACUS Total Parenteral Nutrition Calculation Software. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135694 |
| mdprc 088 05 15 000 | Philips Healthcare | ADAC Vertex and Solus Gamma Camera Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136423 |
| mdprc 087 05 15 000 | Philips Medical Systems | ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136200 |
| mdprc 050 05 15 000 | BD Diagnostic Systems | liquid-based thin layer cell preparation process, PrepStain System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109899 |
| mdprc 049 05 15 000 | Zimmer inc | NexGen Augment | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135840 |
| mdprc 048 05 15 000 | Teleflex Medical | Hudson RCI ConchaTherm Neptune Heated Humidifiers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135428 |
| mdprc 047 05 15 000 | Steris Corp | AMSCO C and AMSCO 400 Steam Sterilizers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135639 |
| mdprc 046 05 15 000 | GE Healthcare | GE Discovery MR950 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134519 |
| mdprc 045 05 15 000 | CareFusion Corp | Vital Signs z Stylets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134609 |
| mdprc 044 05 15 000 | Bard Access Systems | PowerLoc MAX Safety Winged Infusion Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135029 |
| mdprc 043 05 15 000 | B Braun Medical Inc. | CONTIPLEX Continuous Peripheral Nerve Block Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135327 |
| mdprc 038 05 15 000 | Spacelabs Healthcare Inc | Ultraview SL Command Modules | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136025 |
| mdprc 037 05 15 000 | Pega Medical | Fassier-Duval IM Telescopic System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135963 |
| mdprc 036 05 15 000 | Nihon Kohden Corp. | Remote Network Station | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135847 |
| mdprc 035 05 15 000 | Integra LifeSciences | Integra Long Epidural Steroid Injection Needle (Tuohy Needle) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135366 |
| mdprc 034 05 15 000 | Fresenius Kabi Ltd | Fresenius Various 2008 Hemodialysis System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135406 |
| mdprc 033 05 15 000 | Alphatec Spine Inc | 4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135722 |
| mdprc 032 05 15 000 | GE Healthcare | Brivo XR285amx, Optima XR200amx, and Optima XR220amx X-Ray Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135536 |
| mdprc 031 05 15 000 | GA Industries | Logicon Caries Detector | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135053 |
| mdprc 030 05 15 000 | Biocare Medical Llc | CD99 Antibody Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134965 |
| mdprc 029 05 15 000 | Beckman Coulter | MicroScan Pos Combo Panel Type 33 (PC33) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135479 |
| mdprc 001 05 15 000 | PhotoMedex | Iamin Moist Dressing and the Iamin Hydrating Gel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135054 |
| mdprc 144 04 15 000 | OriGen Biomedical | Reinforced Dual Lumen ECMO Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135794 |
| mdprc 143 04 15 000 | Lumenis Inc | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135279 |
| mdprc 142 04 15 000 | CSA Medical | Model CC3-01 truFreeze Consoles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135174 |
| mdprc 141 04 15 000 | Siemens Healthcare Diagnostics | MicroScan Neg Breakpoint Combo 34 panel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135379 |
| mdprc 124 04 15 000 | Specialty Appliances | Herbst Universal Nut | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135031 |
| mdprc 123 04 15 000 | X Spine Systems Inc | Xpress System Pedicle Screw Assembly | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134646 |
| mdprc 112 04 15 000 | Thermedx LLC | Fluid Management System P4000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132087 |
| mdprc 111 04 15 000 | Del Mar Reynolds Medical, Ltd. | Spacelabs Pediatric Flow Sensor Kit for Blease 700/900 Series Ventilators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134610 |
| mdprc 110 04 15 000 | Catheter Research, Inc | HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray Shapeable | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135723 |
| mdprc 096 04 15 000 | Vitrolife, Inc. | SpermMar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132286 |
| mdprc 082 04 15 001 | Bard Pcripheral Vascular (BPV) | Monopty Disposable Biopsy Instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134572 |
| mdprc 083 04 15 000 | Hardy Diagnostics | HardyCHROM SS Agar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134635 |
| mdprc 077 04 15 000 | Baylis Medical Corp | ProTrack Microcatheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135430 |
| mdprc 062 04 15 000 | Teleflex Medical | VasoNova Vascular Positioning System (VPS ) G4 Console Catalog | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135563 |
| mdprc 061 04 15 000 | Lusys Laboratories, Inc. | Multiple Ebola test kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134408 |
| mdprc 050 04 15 000 | Teleflex Medical | Pluer-evac Sahara Chest Drainage System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134560 |
| mdprc 049 04 15 000 | Siemens Healthcare Diagnostics | ADVIA Chemistry XPT System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134088 |
| mdprc 048 04 15 000 | Siemens Healthcare Diagnostics | QuikLYTE(R) Dilution Check | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134171 |
| mdprc 047 04 15 000 | Cooper Surgical, Inc. | TransWarmer Infant Transport Mattress | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133340 |
| mdprc 046 04 15 000 | Civco Medical Instruments Inc | CIVCO Surgi-Tip Transducer Cover | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134563 |
| mdprc 045 04 15 000 | Bacterin International, Inc | Instrument Kit for use with OsteoSponge SC grafts | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134592 |
| mdprc 029 04 15 000 | TEM Systems Inc | ROTROL P | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134494 |
| mdprc 028 04 15 000 | Biomet Inc | Ziploop Button & ToggleLoc | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134383 |
| mdprc 027 04 15 000 | C.R. Bard, Inc | Urinary Drainage Bags. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134365 |
| mdprc 026 04 15 000 | Edwards Lifesciences | Fem-Flex II Femoral Arterial Cannula | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134907 |
| mdprc 025 04 15 000 | GE Healthcare | Aespire 7900, Aespire View | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134476 |
| mdprc 024 04 15 000 | Nidek Co. Ltd. | YC1800 OPHTHALMIC YAG LASER SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134065 |
| mdprc 023 04 15 000 | QUEST Medical Inc. | LIS27T Lacrimal Intubation Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134177 |
| mdprc 013 04 15 000 | DePuy Orthopaedics, Inc | RECLAIM Assembled Implant Inserter Adaptor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134495 |
| mdprc 145 03 15 000 | Zimmer inc | NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134147 |
| mdprc 144 03 15 000 | TITAN SPINE | Endo TCS Driver Straight Hexalobe #6 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134071 |
| mdprc 143 03 15 000 | Microtek Inc. | FreedomAire Helmet Systems and Motor Modules and Smoke Evacuation Components | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134545 |
| mdprc 142 03 15 000 | Ameda, Inc | Ameda One-Hand Manual Breast Pump & Dual Short Term HygieniKit Milk Collections System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134106 |
| mdprc 141 03 15 000 | Ossur | The Rheo Knee bionic prosthetic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134496 |
| mdprc 140 03 15 000 | In2Bones, SAS | DUAFIT(R) PIP 0o CA SIZE 2 & SIZE 3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134574 |
| mdprc 104 03 15 000 | Leica Microsystems, Inc. | Liquid Mouse Monoclonal Antibody CD15 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132240 |
| mdprc 102 03 15 000 | Penner Mfg Inc | Penner Patient Stretcher/Transfer Lift System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132324 |
| mdprc 101 03 15 000 | Intuitive Surgical Inc | da Vinci Xi Surgical System, IS4000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134524 |
| mdprc 100 03 15 000 | GE Inspection Technologies, LP | x|argos 160D & x|tome|x L240 X-ray systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134149 |
| mdprc 099 03 15 000 | Cooper Surgical, Inc. | WarmGel and Liquid Infant Heel Warmers Labeled with "PRISM Healthcare" | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133302 |
| mdprc 085 08 14 001 | Cardiovascular Systems, Inc | Diamondback 360 Peripheral Orbital Atherectomy System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134565 |
| mdprc 091 03 15 000 | Baxter Healthcare | The HomeChoice Pro APD System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123221 |
| mdprc 089 03 15 000 | Ossur. | LP Rotate Foot System prosthetic device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134240 |
| mdprc 088 03 15 000 | SIEMENS | ARTISTE MV System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131894 |
| mdprc 087 03 15 000 | St. Jude Medical Inc | TactiSys Quartz Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133892 |
| mdprc 079 03 15 000 | Synthes Inc | Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133826 |
| mdprc 078 03 15 000 | Dako Inc | Autostainer Plus Link Instruments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134032 |
| mdprc 076 03 15 000 | Zimmer inc | Persona Trabecular Metal Tibial Plates | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133978 |
| mdprc 075 03 15 000 | US Infusion Inc dba Trucare Biomedix-USA | Medstream 81" (206 cm) 20 drop Universal Administration Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132319 |
| mdprc 074 03 15 000 | Puritan Medical Products Co., LLC | Puritan absorbent foam tipped applicator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132741 |
| mdprc 073 03 15 000 | Med-logics Inc | ML 7090 Calibrated LASIK Blade | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133234 |
| mdprc 072 03 15 000 | Bard Access Systems | BD Posiflush Saline Flush Syringe 10 ml | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133939 |
| mdprc 056 03 15 000 | Medela Inc | NuTrio Sterile Enteral Feeding Syringes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134006 |
| mdprc 053 03 15 000 | Synthes Inc | Synthes Inserter for Titanium Elastic Nails | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134076 |
| mdprc 050 03 15 000 | MAQUET Cardiovascular LLC | Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133942 |
| mdprc 048 03 15 000 | Villa Radiology Systems LLC | Juno DRF system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132618 |
| mdprc 047 03 15 000 | Pivotal Health Solutions | Apollo (cold) Laser Desktop Control Units | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133854 |
| mdprc 046 03 15 000 | Depuy Orthopaedics | SMARTSET GHV Gentamicin Bone Cement | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133929 |
| mdprc 026 03 15 000 | Zipline Medical | Zip 8M , Zip 8M & Zip 16 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133841 |
| mdprc 025 03 15 000 | Richard Wolf | The I-Cart | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133375 |
| mdprc 024 03 15 000 | Cooper Surgical, Inc. | CooperSurgical PESSARY | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133919 |
| mdprc 023 03 15 000 | Zimmer inc | Zimmer Segmental System (ZSS) Cemented Stem | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133917 |
| mdprc 022 03 15 000 | Arjo Hospital Equipment AB. | Rotoprone, TriaDyne Proventa Critical Care & RotoRest Delta Advanced Therapy Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133850 |
| mdprc 016 03 15 000 | AngioDynamics Inc | Starburst MRI Semi-Flex Electrode Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133427 |
| mdprc 122 02 15 000 | Intuitive Surgical Inc | EndoWrist One Vessel Sealers Used with da Vinci Si and Xi Surgical Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133842 |
| mdprc 115 02 15 000 | MAKO Surgical Corp | Robotic Arm Interactive Orthopedic System (RIO). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133374 |
| mdprc 114 02 15 000 | Haemonetics Corp. | Haemonetics TEG Hemostasis System Level II Control | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133242 |
| mdprc 113 02 15 000 | Cincinnati Sub-Zero Products Inc | CT99 Cold Therapy Pad | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132502 |
| mdprc 112 02 15 000 | Caesarea Medical Electronics Ltd | CME America BodyGuard 323 Infusion Pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132890 |
| mdprc 094 02 15 000 | Biomet Inc | Ringloc Acetabular Shell Limited Hole Finned 52mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133703 |
| mdprc 093 02 15 000 | Biomet Inc | Mallory Head 4 Finned Acetabular Shell 50mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133700 |
| mdprc 092 02 15 000 | SIEMENS | Artis One | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133162 |
| mdprc 091 02 15 000 | Teleflex Medical | Hudson RCI Sheridan / Preformed, Uncuffed Tracheal Tube, Nasal | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132631 |
| mdprc 090 02 15 000 | Zimmer inc | GemLock Long Hex Driver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132929 |
| mdprc 081 02 15 000 | Medical Components, Inc.. | HEMOCATH, SLX, PROPICC, VASCUPICC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133239 |
| mdprc 080 02 15 000 | Arrow International Inc | ARROWguard Blue PLUS Pressure Injectable Two-Lumen CVC Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132409 |
| mdprc 079 02 15 000 | Arrow International Inc | ARROW Epidural Needle Component | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132410 |
| mdprc 065 02 15 000 | Virtual Imaging, Inc. | Virtual Imaging RadPRO 40 kW | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130399 |
| mdprc 064 02 15 000 | SIEMENS | ACUSON S2000 Automated Breast Volume Scanner (ABVS) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133279 |
| mdprc 063 02 15 000 | SCC Soft Computer | SoftPath Laboratory Information System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131609 |
| mdprc 062 02 15 000 | Radiometer America Inc | ABL90 FLEX analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132250 |
| mdprc 061 02 15 000 | SIEMENS | LINAC Accelerators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132297 |
| mdprc 060 02 15 000 | Shape Medical Systems, Inc | Shape Disposable Patient Interface | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132323 |
| mdprc 059 02 15 000 | Intuitive Surgical Inc | da Vinci Si Surgical System, IS3000, EndoWrist Stapler 45 System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132453 |
| mdprc 024 02 15 000 | Stryker Howmedica Osteonics Corp | Trident PSL HA Solid Back 50 mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132247 |
| mdprc 023 02 15 000 | Fresenius Kabi Ltd | Fresenius Crit Line in a Clip (CLiC) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132856 |
| mdprc 018 02 15 000 | SCC Soft Computer | SoftLab laboratory information system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132127 |
| mdprc 017 02 15 000 | Baxter Healthcare | Baxter Integrated APD Set with Cassette 3-Prong | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132197 |
| mdprc 015 02 15 000 | Fresenius Kabi Ltd | HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132221 |
| mdprc 014 02 15 000 | Orthosensor | VERASENSE KNEE SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132050 |
| mdprc 013 02 15 000 | Baxter Healthcare | HomeChoice/HomeChoice Pro Automated Personal Cycler | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132608 |
| mdprc 012 02 15 000 | Animas Corporation | Animas Vibe Insulin Infusion Pump. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130189 |
| mdprc 008 02 15 000 | Innokas Medical | CARESCAPE VC150 Vital Signs Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132205 |
| mdprc 126 01 15 000 | Aesculap | Aesculap Miethke Shunt System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132226 |
| mdprc 124 01 15 000 | Baxter Healthcare | Four Lead TUR Irrigation Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132249 |
| mdprc 123 01 15 000 | Fresenius Kabi Ltd | Fresenius ASSEMBLY, POWER SUPPLY 130V 50HZ | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132154 |
| mdprc 103 01 15 000 | BD Biosciences | Anti-Lambda APC-H7 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132254 |
| mdprc 102 01 15 000 | Stryker Instruments | The SurgiCounter Charging Cradle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132241 |
| mdprc 101 01 15 000 | TransMotion Medical Inc | Pendant Controls on TMM5 Series Stretcher-Chairs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131309 |
| mdprc 100 01 15 000 | SIEMENS | ADVIA Chemistry XPT System and the CentraLink™ Data Management System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132219 |
| mdprc 099 01 15 000 | Philips Healthcare | TcG10 Transcutaneous Gas Measurement Modules on IntelliVue Patient Monitors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131452 |
| mdprc 098 01 15 000 | Med Tec Inc | Civco, MTSR03 & MTSR02 Shoulder Retractors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132168 |
| mdprc 097 01 15 000 | Ferno Washington Inc | Ferno Model 35X PROFlexx Stretchers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132060 |
| mdprc 090 01 15 000 | Biomet Spine, LLC | Timberline Anchored Lateral Variable Retractable Sleeve | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132196 |
| mdprc 084 01 15 000 | Stelkast Co | EXp Tibial Insert | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132223 |
| mdprc 083 01 15 000 | SpineFrontier Inc | SpineFrontier PedFuse Pedicle Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132251 |
| mdprc 082 01 15 000 | SIEMENS | SOMATOM Force | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132029 |
| mdprc 081 01 15 000 | Ortho-Clinical Diagnostics | VITROS 5600 Integrated System, VITROS 3600 Immunodiagnostic System & VITROS 4600 Chemistry System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131874 |
| mdprc 079 01 15 000 | Biocare Medical Llc | MUM-1 (Multiple myeloma oncogene-1) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132108 |
| mdprc 078 01 15 000 | Medtronic | POWEREASE™ | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132161 |
| mdprc 076 01 15 000 | GE Healthcare | Brivo 715 Prime & Brivo 865 Plus Mobile C-Arm X-Ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131285 |
| mdprc 035 01 15 001 | Trumpf Medical Systems, Inc. | JUPITER Operating Tables | MHRA |
| mdprc 060 01 15 000 | Stryker Orthopaedics | Imbibe Bone Marrow Aspiration Needle & Imbibe Aliquot Needle Bone Cement Needle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132062 |
| mdprc 059 01 15 000 | Steris Corp | Harmony vLED Surgical Lighting System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132078 |
| mdprc 058 01 15 000 | Centurion Medical Products | Multiple surgical trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132234 |
| mdprc 057 01 15 000 | Abbott | The Abbott m2000sp | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130190 |
| mdprc 033 01 15 000 | Exactech | Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130723 |
| mdprc 032 01 15 000 | Mckesson | McKesson Cardiology ECG Management | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132318 |
| mdprc 031 01 15 000 | Spinal Modulation | Ti-Bond Marketing Literature/Labeling | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132185 |
| mdprc 027 01 15 000 | Zimmer inc | Trilogy Cups | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131584 |
| mdprc 026 01 15 000 | HeartSync Inc | Multi-function Defibrillation Electrodes Used with Philips HeartStart Defibrillators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132024 |
| mdprc 011 01 15 000 | Zimmer inc | Osteobond Copolymer Bone Cement | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131930 |
| mdprc 010 01 15 000 | Nonin Medical, Inc. | Regional Oximetry Sensor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132186 |
| mdprc 009 01 15 000 | Alere | INRatio Monitors, INRatio 2 Monitors, Alere INRatio PT/INR Test Strips, Alere INRatio | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132045 |
| mdprc 166 12 14 000 | Smiths Medical | 20 G × 1-Inch Needle-Pro EDGE Safety Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131691 |
| mdprc 165 12 14 000 | MAQUET Cardiovascular LLC | Maquet QuadroxID Pediatric Diffusion Membrane Oxygenator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131553 |
| mdprc 164 12 14 000 | Unistrip Technologies LLC | UniStrip1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131711 |
| mdprc 162 12 14 000 | Ebi, Llc | SolitaireC Cervical Spacer System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132064 |
| mdprc 149 12 14 000 | Zimmer inc | Persona Cemented Tibial Broach Inserters/Extractor Handles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131934 |
| mdprc 148 12 14 000 | Zimmer inc | NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131726 |
| mdprc 147 12 14 000 | US Endoscopy | UroSeal Adjustable Endoscopic Valve. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131574 |
| mdprc 146 12 14 000 | Ortho-Clinical Diagnostics | VITROS CHEMISTRY PRODUCTS TRIG Slides. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131547 |
| mdprc 145 12 14 000 | HORIBA ABX Diagnostics | Lite DM (Lite Data Manager). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131698 |
| mdprc 144 12 14 000 | Cyberonics Inc | Cyberonics VNS Therapy AspireHC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131684 |
| mdprc 133 12 14 000 | Integra LifeSciences | Ascension Orthopedics PyroSphere CMC & PyroSphere TMT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131421 |
| mdprc 132 12 14 000 | Eyemart Express Ltd | Prescription eyeglass safety lenses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130267 |
| mdprc 131 12 14 000 | Biomet | Biomet Spine Durango Anchored ALIF Plate. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131149 |
| mdprc 130 12 14 000 | Medtronic Limited | Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131456 |
| mdprc 023 09 14 001 | Customed, Inc | Customed multiple packs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131036 |
| mdprc 124 12 14 000 | Mindray DS USA, Inc., dba Datascope Patient Monitoring | Mindray DPM 6 and DPM 7 Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131541 |
| mdprc 123 12 14 000 | MAKO Surgical Corp | RESTORIS PST Straight Shell Inserters and Acetabular Shell Inserters | Z-0828-2015, Z-0829-2015, Z-0830-2015 |
| mdprc 128 06 14 001 | JAS Diagnostics Inc.( subsidiary of ERBA Diagnostics ) | Glucose Hexokinase Liquid Reagent | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131170 |
| mdprc 122 12 14 000 | Carestream Health Inc Div Onex Corp | CARESTREAM DIRECTVIEW CR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131396 |
| mdprc 120 12 14 000 | GE Healthcare | Centricity Enterprise Archive 4.0 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117004 |
| mdprc 118 12 14 000 | Varian Medical Systems | Varian On-Board Imager Advanced Imaging System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131207 |
| mdprc 117 12 14 000 | Stryker Spine | Specialty Audible Torque Wrench for the Xia 3 Spinal System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131536 |
| mdprc 116 12 14 000 | SAM Medical Products | SAM Junctional Tourniquet (SJT) Auxiliary | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130412 |
| mdprc 115 12 14 000 | Philips Medical Systems | Philips Healthcare Brilliance iCT/Brilliance iCT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130286 |
| mdprc 114 12 14 000 | Cure Medical LLC | The Cure Pediatric Catheter 10Fr | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131446 |
| mdprc 094 12 14 000 | Stryker Endoscopy | 1488 HD 3-Chip endoscope Camera | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131432 |
| mdprc 093 12 14 000 | Mevion Medical Systems, Inc. | MEVION S250 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131530 |
| mdprc 092 12 14 000 | Invacare Corporation. | Perfecto 2 V Oxygen Concentrator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130540 |
| mdprc 091 12 14 000 | INO Therapeutics (dba Ikaria) | INOMAX DSIR Nitric Oxide delivery system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131204 |
| mdprc 090 12 14 000 | ConforMIS | Conformis iTotal CR G2 Knee Replacement System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131727 |
| mdprc 054 12 14 000 | Summit Medical, Inc. | Summit Industries Floor Mounted Tubestand | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131205 |
| mdprc 052 12 14 000 | Bard Access Systems | GuardIVa Antimicrobial Hemostatic IV Dressing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131344 |
| mdprc 046 12 14 000 | Cooper Surgical, Inc. | CooperSurgical LEEP RADIUS LOOP ELECTRODE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131206 |
| mdprc 008 12 14 000 | Toshiba American Medical Systems Inc | Aquilion One vision, Cardiac Function Analysis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131461 |
| mdprc 007 12 14 000 | Synthes Inc | SynthesTitanium Polyaxial Reduction Head for Titanium Matrix Spine Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131023 |
| mdprc 116 11 14 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista Systems HbA1c Flex Assays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130530 |
| mdprc 115 11 14 000 | Remel | Remel TB Potassium Permanganate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131196 |
| mdprc 114 11 14 000 | Owens & Minor | MediChoice Dual-Release Adult Folding Walkers with 5-Inch Wheels | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128647 |
| mdprc 113 11 14 000 | Intuitive Surgical Inc | da Vinci Xi" Surgical System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131235 |
| mdprc 097 11 14 000 | Synthes Inc | Titanium Cannulated Trochanteric Fixation Nail 170 MM Sterile | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131346 |
| mdprc 096 11 14 000 | Silver Star Brands | Transport Chair and Rollator in 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130754 |
| mdprc 095 11 14 000 | Roscoe Medical Inc | Roscoe Transport Rollator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130304 |
| mdprc 094 11 14 000 | Medtronic Vascular | Medtronic Launcher Coronary Guide Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130755 |
| mdprc 093 11 14 000 | Maquet Cardiopulmonary AG. | CARDIOHELP-i Systems. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130939 |
| mdprc 061 11 14 000 | Zimmer inc | Persona Stemmed 5 Degree Cemented Tibia | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130414 |
| mdprc 060 11 14 000 | Steris Corp | Model 5085 and Model 5085SRT Surgical Tables | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130736 |
| mdprc 059 11 14 000 | St. Jude Medical Inc | Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130784 |
| mdprc 058 11 14 000 | Siemens Healthcare Diagnostics GmbH | Rapid Neg Urine Combo Panel Type 1 & Type 3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130889 |
| mdprc 057 11 14 000 | Dokitz NovoSci | Clear PAY Connector | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130883 |
| mdprc 056 11 14 000 | Davol, Inc. | Bard® PerFix Light Plug | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130721 |
| mdprc 030 11 14 000 | Terumo Cardiovascular Systems Corporation | Cardioplegia Solution Administration Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98878 |
| mdprc 028 11 14 000 | Merit Medical Systems Inc | Merit Maestro Microcatheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130706 |
| mdprc 027 11 14 000 | Joerns Healthcare Ltd | Joerns EasyCare Bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130433 |
| mdprc 026 11 14 000 | Coloplast Manufacturing | Coloplast Conveen Urine Collection Leg Bag | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130457 |
| mdprc 013 11 14 000 | Tecan | Freedom EVO-2 100 Base Unit, with Air LiHa Arms | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130313 |
| mdprc 012 11 14 000 | Siemens Healthcare Diagnostics GmbH | Siemens Dimension Phenytoin Flex Reagent Cartridge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130331 |
| mdprc 011 11 14 000 | Merge Healthcare Corp. | Merge Hemo Programmable diagnostic computer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130438 |
| mdprc 010 11 14 000 | Cooper Surgical, Inc. | Blunt Hurd Cannula Blunt Tip 10mm with 5mm Reducer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130631 |
| mdprc 005 11 14 000 | Briggs Medical Service Company | DMI Rollator Transport Chair | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117032 |
| mdprc 019 06 14 001 | C P Medical | Monoswift PGCL | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130358 |
| mdprc 115 10 14 000 | Trumpf Medical Systems, Inc. | TITAN Operating Tables | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130513 |
| mdprc 104 10 14 000 | Vygon Corporation | Bionector Needleless connector | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129862 |
| mdprc 103 10 14 000 | St. Jude Medical Inc | 10F Fast-Cath Trio" Hemostasis Introducer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130765 |
| mdprc 102 10 14 000 | Signal Medical Corporation | Symmetric Total Knee Femoral Components | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130498 |
| mdprc 101 10 14 000 | Olympus | Various Everest and PKS Forceps and Scissors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129976 |
| mdprc 100 10 14 000 | Estill Medical Technologies, Inc | Estill Ultra Battery 1 Batteries Used with Thermal Angel Blood and IV Fluid Warming Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130149 |
| mdprc 099 10 14 000 | Intra Pump Infusion Systems | CRN Crono Syringe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122569 |
| mdprc 098 10 14 000 | Philips Healthcare | Philips IntelliVue Monitors & Philips Avalon Monitors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130270 |
| mdprc 097 10 14 000 | Philips Respironics California | Esprit V1000 Ventilator, V200 Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130205 |
| mdprc 086 10 14 000 | Zimmer inc | Continuum Hip Cups | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130191 |
| mdprc 085 10 14 000 | DeRoyal Industries Inc | Suction canisters & SafeLiner Suction Canister Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130223 |
| mdprc 081 10 14 000 | Arjo Huntleigh | Maxi Sky 2 Medium 2 Point Spreader Bar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114969 |
| mdprc 080 10 14 000 | Arrow International Inc | Multi-Lumen Central Venous Catheterization Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130176 |
| mdprc 073 10 14 000 | Merge Healthcare Corp | eFilm Workstation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130185 |
| mdprc 072 10 14 000 | KCI USA Inc | V.A.C. GranuFoam Silver Dressing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130310 |
| mdprc 092 09 14 001 | Peters Surgical | The synthetic non-absorbable surgical sutures CARDIOFLON Evolution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128565 |
| mdprc 032 10 14 000 | OrthoHelix Surgical Design Inc | MaxLock Extreme Mod-Foot Concave Reamer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130183 |
| mdprc 031 10 14 000 | Richard-Allan Scientific | Richard-Allan 10% Neutral Buffered Formalin Reagent Products | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130173 |
| mdprc 030 10 14 000 | Biomet Inc | Green Mamba Suture Passer, Mamba Disposable Nitinol Needle & Black Mamba Suture Passer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130294 |
| mdprc 029 10 14 000 | Boston Scientific Ltd | StarMedTec LightTrail Reusable Fibers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130434 |
| mdprc 028 10 14 000 | Smith & Nephew inc | RENASYS EZ/ RENASYS EZ Plus | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129744 |
| mdprc 027 10 14 000 | Nemschoff Chairs, Inc | Serenity Treatment Chair | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129616 |
| mdprc 022 10 14 000 | Biomedix, Inc. | Biomedix SELEC-3 I.V. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130088 |
| mdprc 019 10 14 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products PHYT (Phenytoin) Slides | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129618 |
| mdprc 018 10 14 000 | Baxter Healthcare | SPECTRUM Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129683 |
| mdprc 017 10 14 000 | Zimmer inc | Persona The Personalized Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129382 |
| mdprc 015 10 14 000 | Philips Medical Systems | The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129995 |
| mdprc 008 10 14 000 | Nanosphere, Inc. | Verigene GramPositive | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128491 |
| mdprc 007 10 14 000 | Lumenis Inc | Array LaserLink | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129733 |
| mdprc 006 10 14 000 | Apollo Endosurgery Inc | LAP-BAND AP SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129727 |
| mdprc 060 08 11 001 | Spacelabs Healthcare Inc | Patient monitor, Spacelabs Medical Patient Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129983 |
| mdprc 108 09 14 000 | Philips Medical Systems | Brilliance CT System 6/10/16/16P/40 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129682 |
| mdprc 107 09 14 000 | Pdg Product Design Group Inc | Fuze Manual Tilt Wheelchair | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129375 |
| mdprc 106 09 14 000 | Horiba | ABX PENTRA Magnesium RTU Reagent | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129650 |
| mdprc 105 09 14 000 | Dako North America Inc | Dako Autostainer Link 48 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129827 |
| mdprc 104 09 14 000 | Alcon Laboratories Inc. | eye-pak 7407 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128029 |
| mdprc 093 09 14 000 | Vidacare Corporation | EZ-LO 45 mm Needle Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126593 |
| mdprc 090 09 14 000 | Instratek Incorporated | Mini Cannulated Titanium Headed and Headless Screw Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126167 |
| mdprc 089 09 14 000 | Genesys Orthopedic Systems | The TiLock Pedicle Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126582 |
| mdprc 088 09 14 000 | Fresenius | Fresenius Naturalyte Liquid Bicarbonate Concentrate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129774 |
| mdprc 087 09 14 000 | CareFusion | CareFusion AirLife Heated Infant Breathing Circuit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129107 |
| mdprc 086 09 14 000 | Motion Concepts | TRx Vertical Positioner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129660 |
| mdprc 085 09 14 000 | Genesis BPS, LLC. | Pedi-Pak Pedi-Syringe Filter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128913 |
| mdprc 084 09 14 000 | CareFusion | EnVe and ReVel Ventilators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129356 |
| mdprc 067 09 14 000 | GF Health Products | Zenith Slide W-I-D-E Long Term Care Bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129450 |
| mdprc 056 09 14 000 | JK Products & Services, Inc | SUN DASH RADIUS 252 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129379 |
| mdprc 055 09 14 000 | Fresenius Medical Care | Multiple BD Vacutainer Tubes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128269 |
| mdprc 054 09 14 000 | Dawning Technologies, Inc | ProVue Instrument Driver for JResultNet | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129603 |
| mdprc 053 09 14 000 | BD Biosciences | BD BBLTM Vancomycin Screen Agar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129481 |
| mdprc 050 09 14 000 | AB SCIEX | AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129611 |
| mdprc 049 09 14 000 | Pioneer Surgical Technology | Streamline MIS Spinal Fixation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129377 |
| mdprc 048 09 14 000 | Concentric Medical Inc | Merci Retriever | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129669 |
| mdprc 038 09 14 000 | Zimmer inc | Natural-Knee System Patella Bushings. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129110 |
| mdprc 030 02 14 001 | Spacelabs Healthcare Inc | ARIATELE TELEMETRY TRANSMITTER | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129684 |
| mdprc 037 09 14 000 | Medical Components, Inc. | Split Cath III | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129216 |
| mdprc 036 09 14 000 | Galt Medical Corp | Galt Valved Tearaway Kit & Galt VTI | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129056 |
| mdprc 035 09 14 000 | Catheter Connections, Inc. | DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129487 |
| mdprc 034 09 14 000 | Biomet 3i Inc | Bellatek Encode Healing Abutment | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129004 |
| mdprc 027 09 14 000 | Pioneer Surgical Technology | STREAMLINE CT CERVICO-THORACIC SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129374 |
| mdprc 026 09 14 000 | Hitachi Medical Systems | Hitachi Echelon Oval MRI system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128607 |
| mdprc 025 09 14 000 | Biomet Inc | Total Temporomandibular Joint Replacement System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125711 |
| mdprc 024 09 14 000 | OrthoPediatrics Corp | Sleeve Installation Tool Instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129442 |
| mdprc 022 09 14 000 | Civco Medical Instruments Inc | CollectEVAC Evacuator Irrigation/Tissue Collection Systems. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129097 |
| mdprc 142 08 14 000 | Zimmer inc | Persona Distal Valgus Alignment Guides. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128765 |
| mdprc 128 08 14 000 | Philips Medical Systems | Philips IntelliSpace ECG Management System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129200 |
| mdprc 094 08 14 001 | TomoTherapy Incorporated | TomoTherapy Treatment System, Model: Hi-Art | BfArM |
| mdprc 123 08 14 000 | Synthes Inc | Craniomaxillofacial (CMF) Distraction System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126898 |
| mdprc 107 08 14 000 | Vascutek Limited | Gelweave (TM) Vascular Prostheses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129138 |
| mdprc 106 08 14 000 | Medtronic Neuromodulation | Activa PC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129036 |
| mdprc 105 08 14 000 | Hyperion Medical | HyperBlue 1530, multiuse diode laser | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126389 |
| mdprc 104 08 14 000 | AngioDynamics Inc | UniFuse Infusion System with Cooper Wire | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129196 |
| mdprc 092 08 14 000 | Siemens Healthcare Diagnostics GmbH | Dimension Chemistry Wash.. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128853 |
| mdprc 090 08 14 000 | OMNIlife science | Apex Arc Hip Stem, Size 2, HA Coated | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128142 |
| mdprc 089 08 14 000 | Biomet Inc | Vanguard 360 Revision Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129028 |
| mdprc 087 08 14 000 | Nanosphere, Inc. | Nanosphere Verigene | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128801 |
| mdprc 086 08 14 000 | Covidien LLC | Vital Sync Virtual Patient Monitoring Platform and Informatics Manager | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128766 |
| mdprc 076 08 14 000 | Medical Positioning Inc | Rapid Response HUT table with Dual 2 Way Drop Section | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128617 |
| mdprc 064 08 14 000 | Boston Scientific Ltd | ENDOTAK RELIANCE SG | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128470 |
| mdprc 062 08 14 000 | Nanosphere, Inc. | Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127104 |
| mdprc 061 08 14 000 | Intuitive Surgical Inc | EndoWrist Stapler System User Manual Addendum and Wall Chart | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128783 |
| mdprc 059 08 14 000 | ICU Medical, Inc | Transpac Trifurcated monitoring kit with Safeset Reservoir | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129164 |
| mdprc 054 08 14 000 | Enhancement Medical, LLC | Enhancement Medical expression | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128288 |
| mdprc 053 08 14 000 | Biosound Esaote, Inc | Esaote PA230E Transducer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128485 |
| mdprc 039 08 14 000 | Medical Action Industries Inc | Laceration and Suture Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128221 |
| mdprc 024 08 14 000 | X Spine Systems Inc | Serrated Soft Tissue Shields | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128882 |
| mdprc 023 08 14 000 | Zimmer inc | Zimmer Periarticular Locking Plate System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128400 |
| mdprc 022 08 14 000 | Nidek Co. Ltd. | MC500 Multicolor Laser Photocoagulator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128624 |
| mdprc 021 08 14 000 | Small Bone Innovations | 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127716 |
| mdprc 020 08 14 000 | AdvanDx, Inc | AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128635 |
| mdprc 019 08 14 000 | Stryker Medical | InTouch Critical Care Beds | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127981 |
| mdprc 018 08 14 000 | Terumo Cardiovascular Systems Corporation | Terumo Advanced Perfusion System 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127207 |
| mdprc 012 08 14 000 | Novocol, Inc | Self-Etch bond | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128750 |
| mdprc 011 08 14 000 | DeRoyal Industries Inc | DeRoyal Cardiac Hypothermia Tray & DeRoyal KNEE ARTHROSCOPY PACK | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128592 |
| mdprc 010 08 14 000 | Wellspring Pharmaceutical Corporation | IPM Wound Gel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128183 |
| mdprc 009 08 14 000 | Ra Medical Systems Inc | PHAROS Excimer Laser | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128486 |
| mdprc 008 08 14 000 | Teleflex Medical | Emerald Fiber-Optic Macintosh 4 Laryngoscope Blades | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128606 |
| mdprc 134 07 14 000 | Heartsine Technologies | PadPak and PediPak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128482 |
| mdprc 133 07 14 000 | Dynarex Corporation | CPR Shield With One Way Valve and Barrier Filter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128445 |
| mdprc 132 07 14 000 | Medtronic Inc | Nexdrive Micropositioning Drives Used with Nexframe Stereotactic Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128310 |
| mdprc 080 11 13 001 | Terumo Cardiovascular Systems Corporation | Sarns" SoftFlow Aortic Cannula without Suture Flange & Venous Return Cannulae | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127519 |
| mdprc 128 07 14 000 | Teleflex Medical | Hudson RCI, Breathing Circuit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128577 |
| mdprc 123 07 14 000 | Invacare Corporation. | Invacare Pronto M41 Power Wheelchair | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128337 |
| mdprc 122 07 14 000 | DIABETIC SUPPLY OF SUNCOAST, INC. | Advocate RediCode BMB-BA006A Blood Glucose Test Strips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127125 |
| mdprc 121 07 14 000 | Alphatec Spine Inc | Solanas 2.1mm FIXED DEPTH DRILL, 10mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128421 |
| mdprc 095 07 14 000 | Stryker Endoscopy | Disposable StrykeFlow Tips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128339 |
| mdprc 093 07 14 000 | Spacelabs Healthcare Inc | Spacelabs Healthcare Ultraview SL Multigas Module | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128308 |
| mdprc 092 07 14 000 | Pioneer Surgical Technology | Tritium Sternal Plate System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128318 |
| mdprc 091 07 14 000 | International Technidyne Corporation | Hemocrhon Jr APTT Cuvettes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128402 |
| mdprc 090 07 14 000 | Baxter Healthcare | Baxter MiniCap with ProvidoneIodine Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128280 |
| mdprc 085 07 14 000 | Excelsior Medical Corp | Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128242 |
| mdprc 084 07 14 000 | Innovasis, Inc | Excella II Standard Pedicle Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128657 |
| mdprc 076 07 14 000 | SIEMENS | Symbia E & E.CAM Emission Computed Tomography Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128464 |
| mdprc 075 07 14 000 | Philips Medical Systems | Gemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Bore | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128391 |
| mdprc 074 07 14 000 | Zimmer Manufacturing B.V. | 4.0mm X 20mm Cancellous Screw; 4.0mm X 22mm Fully Threaded Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128171 |
| mdprc 073 07 14 000 | Hospira Inc | The Hospira MedNet Medication Management Suite (MMS). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128401 |
| mdprc 072 07 14 000 | Zimmer inc | M/L Taper and M/L Taper with Kinectiv Hip Stems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127546 |
| mdprc 071 07 14 000 | Thermo Fisher Scientific Inc. | Thermo Scientific VersaTREK REDOX 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128265 |
| mdprc 069 07 14 000 | Zimmer inc | Zimmer Dental Tapered Screw-Vent Implant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128266 |
| mdprc 068 07 14 000 | Shape Medical Systems, Inc | Shape HF Cardiopulmonary System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128263 |
| mdprc 059 07 14 000 | Integra LifeSciences | NewPort Spinal System MIS Rod 2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128087 |
| mdprc 058 07 14 000 | B Braun Medical Inc | Stopcock Extension Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128169 |
| mdprc 056 07 14 000 | Philips Medical Systems | Ingenia 3.0T , Ingenia 1.5T R5, Ingenia 3.0T R5 , Ingenia 1.5T Magnetic Resonance Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128277 |
| mdprc 044 07 14 000 | Vascular Technology, Inc. | VTI BAYONET DOPPLER PROBES & VARIOUS MIZUHO DOPPLER PROBES | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128115 |
| mdprc 043 07 14 000 | RGI Medical Manufacturing, Inc. | Henora Catheter Extension Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128179 |
| mdprc 042 07 14 000 | Kova Laboratories, Inc | Amerigel Wound Dressing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128030 |
| mdprc 041 07 14 000 | Cenorin | HLD System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128261 |
| mdprc 040 07 14 000 | 3M company | 3M Attest Auto-reader | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127541 |
| mdprc 039 07 14 000 | Intuitive Surgical Inc | Multiple Da Vinci Surgical Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128006 |
| mdprc 038 07 14 000 | Global Cooling Inc | Stirling Ultracold Portable Shuttle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127369 |
| mdprc 037 07 14 000 | Focus Diagnostics Inc | Simplexa Flu A/B &38; RSV Direct | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127387 |
| mdprc 036 07 14 000 | Baxter Healthcare | EXACTAMIX Compounder | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128106 |
| mdprc 030 07 14 000 | Ventlab Corp | Resuscitator Bags, manual resuscitator for the Pediatric Population | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127204 |
| mdprc 029 07 14 000 | Stryker Howmedica Osteonics Corp | Stryker Orthopaedics Triathlon Tritanium Patella Inserter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128089 |
| mdprc 028 07 14 000 | Synthes Inc | Synthes B37 Replacement Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127496 |
| mdprc 027 07 14 000 | Integra LifeSciences | Integra® LED Battery Charger | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128129 |
| mdprc 026 07 14 000 | Boston Scientific Corporation | iLab Ultrasound Imaging System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126666 |
| mdprc 023 07 14 000 | Claymount Assembli | Claymount Harmony2 Bucky | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126135 |
| mdprc 021 07 14 000 | Alcon Research, Ltd | Alcon CUSTOM-PAK | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127370 |
| mdprc 020 07 14 000 | Zimmer inc | NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127984 |
| mdprc 019 07 14 000 | Spacelabs Healthcare Inc | Qube Compact Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128034 |
| mdprc 018 07 14 000 | Siemens Healthcare Diagnostics | ADVIA Centaur, ADVIA Centaur XP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128153 |
| mdprc 017 07 14 000 | Meridian Bioscience Inc | illumipro-10 Incubator/Reader | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127512 |
| mdprc 016 07 14 000 | Integra LifeSciences | Accell Evo3c Demineralized Bone Matrix Putty 5 cc | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127361 |
| mdprc 015 07 14 000 | Blue Belt Technologies | Stride Femoral Component | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128024 |
| mdprc 132 06 14 000 | The Anspach Effort, Inc. | Multiple Anspach systems devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115697 |
| mdprc 130 06 14 000 | Stryker Endoscopy | Shaver Handpiece Sterilization Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127531 |
| mdprc 129 06 14 000 | Nitinol Devices and Components, Inc. | HydroFinity Guidewires | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127555 |
| mdprc 127 06 14 000 | Intuitive Surgical Inc | IS4000 da Vinci Xi - Endoscope accessory | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128147 |
| mdprc 105 06 14 000 | Teleflex Medical | RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127500 |
| mdprc 104 06 14 000 | Philips Healthcare | Philips Brilliance CT Big Bore Oncology and Philips Brilliance CT Big Bore Radiology | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126548 |
| mdprc 102 06 14 000 | Integra LifeSciences | Integra UCR 3mm Hex, Large Axial Driver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127469 |
| mdprc 082 06 14 000 | Spacelabs Healthcare Inc | Hamilton Galileo Ventilator Flexport | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127487 |
| mdprc 081 06 14 000 | Ability Dynamics LLC | RUSH81 Prosthetic Foot | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128151 |
| mdprc 072 06 14 000 | Smiths Medical | Portex Low Dead Space Connector with Sideport, 3.5mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126747 |
| mdprc 071 06 14 000 | Ebi, Llc | Cypher MIS Screw Inserter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128143 |
| mdprc 070 06 14 000 | Ortho-Clinical Diagnostics | Calibrator Kit 17 and FS Calibrator 1 Used with VITROS Chemistry Products hsCRP Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127271 |
| mdprc 069 06 14 000 | Boston Scientific Corporation | IntellaTip MiFi XP Temperature Ablation Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127481 |
| mdprc 068 06 14 000 | Biomet Inc | EZPass Suture Retriever Nitinol Single Pack, EZPass Nylon Monofilament Single Pack & EZPass Passer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127167 |
| mdprc 166 02 14 001 | Elekta Limited | Synergy xray volume imaging (XVI); Elekta Synergy; Elekta Synergy S and XVI | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125047 |
| mdprc 057 06 14 000 | Teleflex Medical | Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127366 |
| mdprc 056 06 14 000 | Cooper Surgical, Inc. | Cooper Surgical TAMPA CATHETER 5 French 33 cm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127327 |
| mdprc 055 06 14 000 | Cenorin | HLD Systems (High Level Disinfector) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127201 |
| mdprc 054 06 14 000 | Philips Healthcare | IntelliVue MX40 Patient Monitors used with IntelliVue Information iX Centers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127391 |
| mdprc 053 06 14 000 | Ortho-Clinical Diagnostics | enGen (TM) Laboratory Automation Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127243 |
| mdprc 052 06 14 000 | Cordis Corporation | Cordis EMPIRA RX PTCA Dilatation Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115742 |
| mdprc 051 06 14 000 | Cincinnati Sub-Zero Products Inc | 115 V Blanketrol II, Model 222S Hyper-Hypothermia System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127458 |
| mdprc 042 06 14 000 | Teleflex Medical | RUSCH Easy Cath | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127390 |
| mdprc 041 06 14 000 | Mckesson Information Solutions LLC | Horizon Medical Imaging | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127692 |
| mdprc 039 06 14 000 | Alere | Alere Triage D-Dimer Test | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127185 |
| mdprc 038 06 14 000 | Stryker Instruments | The Stryker NAV3i Platform & The NAV3i Platform Power Box | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127233 |
| mdprc 037 06 14 000 | Medtronic Neuromodulation | Ascenda Intrathecal Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127290 |
| mdprc 036 06 14 000 | Intuitive Surgical Inc | Assembly, Patient Side Cart, for use with da Vinci Surgical system IS 4000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127460 |
| mdprc 020 06 14 000 | Spacelabs Healthcare Inc | Ultraview SL Command Module | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127459 |
| mdprc 013 06 14 000 | Bacterin International, Inc | Elutia Surgical Wound Drain | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127311 |
| mdprc 012 06 14 000 | Synthes Inc | Synthes XRL Medium TrialCentral Body | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126770 |
| mdprc 009 06 14 000 | Fresenius Medical Care | NaturaLyte Bicarbonate Concentrate Bottles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126614 |
| mdprc 003 06 14 000 | DePuySynthes | ProDisc-C 2.0mm Milling Bit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127119 |
| mdprc 001 06 14 000 | B Braun Medical Inc. | Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126847 |
| mdprc 105 05 14 001 | Microline Surgical Inc | Microline Renew Fenestrated Control Tip Grasper | BfArM |
| mdprc 122 05 14 000 | SIEMENS | 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126663 |
| mdprc 121 05 14 000 | Philips Healthcare | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127235 |
| mdprc 120 05 14 000 | Medline Industries Inc. | Esmark Elastic Bandage | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126504 |
| mdprc 119 05 14 000 | Gambro | Revaclear and Revaclear Max Capillary Dialyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126757 |
| mdprc 118 05 14 000 | FUJIFILM Medical Systems | MXR-35 Diagnostic X-ray High Voltage Generator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126664 |
| mdprc 108 05 14 000 | True Air Technologies, Inc | ECATS E 850 and JK Bariatric Bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126957 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126617 |
| mdprc 107 05 14 000 | True Air Technologies, Inc | MaXair True Low Air Loss Mattress Replacement System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126958 |
| mdprc 106 05 14 000 | Terumo Cardiovascular Systems Corporation | CDI Blood Parameter Monitoring System; CDI 500 Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127202 |
| mdprc 104 05 14 000 | Arrow International Inc | Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126459 |
| mdprc 096 05 14 000 | CareFusion.. | Alaris Pump Model 8100 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126894 |
| mdprc 095 05 14 000 | Mindray North America | DPM 6 Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126625 |
| mdprc 094 05 14 000 | Medline Industries Inc. | Mucus Specimen Trap | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123381 |
| mdprc 093 05 14 000 | The Anspach Effort, Inc. | Anspach Irrigation Clip 40 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126801 |
| mdprc 092 05 14 000 | InterValve Inc | InterValve V8 Balloon Aortic Valvuloplasty Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126670 |
| mdprc 091 05 14 000 | Baxter Healthcare | RAPIDFILL Syringe Strip | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126818 |
| mdprc 090 05 14 000 | Fresenius Medical Care | Fresenius 2008T Hemodialysis Machine | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126850 |
| mdprc 089 05 14 000 | McKesson Medical Imaging Group | Picture Archive Communication System (PACS) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127138 |
| mdprc 088 05 14 000 | Ortho Development Corp | PS-C Femoral Nonporous Rt Sz 6 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126817 |
| mdprc 081 05 14 000 | Tenex Health | TX1 Tissue Removal System, TX1 Procedure Pack, TX1 MicroTip | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126906 |
| mdprc 080 05 14 000 | Mar Cor Purification | Central Water Platform (CWP), 102, 104 and 106 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126959 |
| mdprc 079 05 14 000 | AlloSource, Inc | AlloFuse DBM Putty 5cc | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126738 |
| mdprc 076 05 14 000 | Zimmer inc | " Knee Brace, Cartilage Knee Brace, Hinged Knee Support, Tennis Elbow Support | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126805 |
| mdprc 071 05 14 000 | Newport Medical Instruments Inc. | Newport Medical Instruments e360 Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126938 |
| mdprc 059 05 14 000 | Alere | INRatio 2 PT/INR Professional Test Strips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126845 |
| mdprc 024 05 14 000 | Biorep Technologies | Joseph Lamelas Atrial Lift Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126934 |
| mdprc 015 05 14 000 | INO Therapeutics (dba Ikaria) | INOmax DSIR Delivery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126644 |
| mdprc 010 05 14 000 | Hospira Inc | ACCLAIM Encore Infusion Pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125798 |
| mdprc 009 05 14 000 | Arrow International Inc | Arrowgard Blue Plus Antimicrobial Multilumen Central Venous Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126460 |
| mdprc 006 05 14 000 | Alfa Wassermann, Inc. | ACE AST Reagent Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126580 |
| mdprc 096 08 13 001 | Fisher Scientific Co | Wood Applicator Swab, Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120307 |
| mdprc 161 04 14 000 | Teleflex Medical | Monodek Violet Synthetic Absorbable Surgical Sutures | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126704 |
| mdprc 160 04 14 000 | Acumed LLC | The Acumed Tension Band Pin & The Osteo-Clage System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126602 |
| mdprc 152 04 14 000 | Branan Medical Corporation | ToxCup Drug Screen Cup | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126393 |
| mdprc 151 04 14 000 | Philips Medical Systems | Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126532 |
| mdprc 150 04 14 000 | Teleflex Medical | Tubes, Sengstaken Tube and Sengstaken-Blakemore Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125902 |
| mdprc 149 04 14 000 | Ion Beam Applications S.A. | Proteus 235 Proton Therapy System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126051 |
| mdprc 148 04 14 000 | Zimmer inc | TRABECULAR METAL" MODULAR ACETABULAR SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126336 |
| mdprc 147 04 14 000 | Arrow International Inc | Pressure Injectable PICC Powered by Arrow VPS Stylet | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126455 |
| mdprc 146 04 14 000 | Stryker | PenAdapt Aspiration Sheaths Used with Neptune 2 Ultra Rover Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126202 |
| mdprc 145 04 14 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125634 |
| mdprc 138 04 14 000 | Merit Medical Systems Inc | Merit Laureate Hydrophilic Guide Wire | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126848 |
| mdprc 137 04 14 000 | Hospira Inc | HemoSet Dual-Channel PlumSet Blood Administration Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126148 |
| mdprc 131 04 14 000 | Spacelabs Healthcare Inc | Anesthesia Systems , Arkon Anesthesia Delivery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126320 |
| mdprc 119 04 14 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products CRBM Slides. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126327 |
| mdprc 117 04 14 000 | Codman & Shurtleff Inc | CODMAN CERTAS" Programmable Valves | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126333 |
| mdprc 116 04 14 000 | Terumo Cardiovascular Systems Corporation | Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126616 |
| mdprc 115 04 14 000 | SIEMENS | AXIOM Vertix MD Trauma systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126309 |
| mdprc 114 04 14 000 | CareFusion Inc, | SmartSite Extension Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126255 |
| mdprc 113 04 14 000 | Philips Medical Systems | Computed Tomography X-ray systems, Ingenuity Core 128 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126256 |
| mdprc 112 04 14 000 | Biomet 3i Inc | Endosseous Dental Implant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125833 |
| mdprc 111 04 14 000 | Newport Medical Instruments Inc | Newport HT70 and HT70 Plus Ventilators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111914 |
| mdprc 109 04 14 000 | Synthes Inc | Synthes CMF Battery Powered Driver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125578 |
| mdprc 093 04 14 000 | Ergosafe Products LLC | Medcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assembly | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126363 |
| mdprc 092 04 14 000 | Gambro | Hemodialysis Tubing Sets, Gambro Cartridge Blood Set blood transport system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126338 |
| mdprc 090 04 14 000 | Central Purchasing LLC DBA Harbor Freight Tools | Sit/stand Rolling Walker | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126545 |
| mdprc 089 04 14 000 | Remington Medical | FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126209 |
| mdprc 082 04 14 000 | Teleflex Medical | Rusch Brochopart and Rusch Brochopart White | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125870 |
| mdprc 081 04 14 000 | Aspen Surgical Products, Inc. | Multiple drain Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126229 |
| mdprc 074 04 14 000 | 3M Health Care Ltd | 3M Steri-Vac Gas Sterilizer/Aerators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126136 |
| mdprc 073 04 14 000 | Ormco Corp. | Titanium Orthos Brackets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126506 |
| mdprc 072 04 14 000 | Stryker | Prostheses, Joint, Hip, Femoral Component, Citation TMZF Hip Stems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126186 |
| mdprc 071 04 14 000 | Energizer Personal Care | Playtex Nurser Deluxe Double Electric Breast Pump | Z-1336-2014 |
| mdprc 070 04 14 000 | Intuitive Surgical Inc | 5 mm Cannulae Used with da Vinci Si Surgical Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126237 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126239 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126240 , http://www.accessdata.fda. |
| mdprc 069 04 14 000 | Merit Medical Systems Inc | Merit Custom Syringe Kit & Pressure Monitoring Tubing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126485 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126484 |
| mdprc 068 04 14 000 | Ormco Corp. | Spirit MB Bracket | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126492 |
| mdprc 018 04 14 000 | Allesee Orthodontic Appliances | Distalizer Lock Nut Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125897 |
| mdprc 003 04 14 000 | Abbott Laboratories Inc | i-STAT G3+ Reagent Cartridges | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125647 |
| mdprc 002 04 14 000 | Biocardia, Inc. | Catheter Introducer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126128 |
| mdprc 001 04 14 000 | Bard Access Systems | PowerPort Slim Implantable Port | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125727 |
| mdprc 140 03 14 000 | Gyrus ACMI | Disposable Falope-Ring Band Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125747 |
| mdprc 139 03 14 000 | Teleflex Medical | Multiple sutures with Needle Attachments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126183 |
| mdprc 135 03 14 000 | ConvaTec | Curion CuriStay Nelaton, Medline Sterile Foley Catheter, 'TORAY' Hydrocoat Foley Catheter, SLC 2-way standard Lubricious, JMS, SLC 3-way standard Lubricious | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126152 |
| mdprc 130 03 14 000 | Velocity Medical Solutions, LLC | DICOM Export Format for Sum Dose with Velocity v3.0.0 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125842 |
| mdprc 129 03 14 000 | Leica Microsystems, Inc. | Microscopes, ScanScope System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125499 |
| mdprc 128 03 14 000 | Stryker Communications | 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126273 |
| mdprc 127 03 14 000 | Philips Healthcare | Ultrasound Systems, EPIQ 7 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126067 |
| mdprc 125 03 14 000 | Clarity Medical Systems Inc | Halogen Lamp component in RetCam 3 System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126097 |
| mdprc 124 03 14 000 | Biomet Inc | Intramedullary Bone Saw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125847 |
| mdprc 122 03 14 000 | Zimmer inc | Various Polyethylene Prostheses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125635 |
| mdprc 118 03 14 000 | Terumo Cardiovascular Systems Corporation | Sarns Malleable Dual-stage Venous Return Cannulae, Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125812 |
| mdprc 023 03 14 001 | Medical Information Technology, Inc. | IVD, MEDITECH Microbiology | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125769 |
| mdprc 117 03 14 000 | Exactech | Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125540 |
| mdprc 107 03 14 000 | China Daheng Group Inc. | Denlase and Penlase Dental Laser Systems. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125664 |
| mdprc 085 03 14 000 | Elekta Limited | SL & SLi Series (Mod 15/18/20/25) Linear Accelerator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118950 |
| mdprc 084 03 14 000 | DeRoyal Industries Inc. | DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126065 |
| mdprc 064 08 11 003 | Vital Signs Inc A GE Healthcare Co | Vital Signs enFlow IV Fluid Warmers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103330 |
| mdprc 053 03 14 000 | Philips Respironics | Trilogy Ventilator Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125712 |
| mdprc 052 03 14 000 | Steris Corp | VERIFY SixCess 270FP Challenge Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125270 |
| mdprc 051 03 14 000 | Boston Scientific Corporation | Boston Scientific, RunWay" Guide Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125921 |
| mdprc 048 03 14 000 | Mindray North America | Panorama Central Station Patient Monitoring Systems. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125558 |
| mdprc 047 03 14 000 | Megadyne Medical Products Inc | Hand Control 12FR Suction Coagulator with 10 ft cord and holster | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125887 |
| mdprc 046 03 14 000 | Hospira Inc | LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124587 |
| mdprc 045 03 14 000 | GE Healthcare | Monitor, GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125349 |
| mdprc 044 03 14 000 | GE Healthcare | Computed Tomography X-Ray system, GSI Viewer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121519 |
| mdprc 040 03 14 000 | Toshiba American Medical Systems Inc | TSX-301C Aquilion One (Vision Edition) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125035 |
| mdprc 039 03 14 000 | KCI USA Inc | Wound Dressing Connectors Used with Prevena Incisional Management Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125480 |
| mdprc 038 03 14 000 | MEDICAMAT S.A. | Punch Hair Matic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125432 |
| mdprc 037 03 14 000 | DJO Surgical | FMP X-alt Acetabular Liner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125512 |
| mdprc 036 03 14 000 | AlterG, Incorporated | AlterG Anti-Gravity Treadmill | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125448 |
| mdprc 035 03 14 000 | DeRoyal Industries Inc. | Circumcision Clamps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125456 |
| mdprc 034 03 14 000 | Synthes Inc | Synthes 5.0mm Variable Locking Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125573 |
| mdprc 033 03 14 000 | MAKO Surgical Corp | Restoris Multicompartmental Knee (MCK) System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125464 |
| mdprc 035 02 14 001 | CareFusion | SmartSite Needle-Free Connectors | http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00119-1 |
| mdprc 022 03 14 000 | Toshiba American Medical Systems Inc | Multiple Aquilion Computed Tomography X-Ray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122559 |
| mdprc 020 03 14 000 | WalkMed Infusion, LLC | Triton FP Infusion Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125700 |
| mdprc 013 03 14 000 | Philips Medical Systems | Philips HeartStart XL | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125534 |
| mdprc 012 03 14 000 | Ossur | The SYMBIONIC LEG | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125090 |
| mdprc 011 03 14 000 | Philips Healthcare | Defibrillators, HeartStart MRx Monitor / Defribillator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125533 |
| mdprc 010 03 14 000 | Philips Medical Systems | Defibrillators, Philips HeartStart XL+ Defibrillator/Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125269 |
| mdprc 009 03 14 000 | Fresenius Medical Care | Fresenius Optiflux F160NRe, F200NRe , F200NR, F200A, B200, F180NR, F160NR, F180NRe and F18Nre Flux Dialyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125235 |
| mdprc 007 03 14 000 | Philips Healthcare | Philips HeartStart MRx Monitor/Defribillator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125539 |
| mdprc 006 03 14 000 | Stryker Spine | Straight Static Inserter Assembly MFG Part of the AVS navigator Peek Spacer System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125385 |
| mdprc 167 02 14 000 | NxStage Medical, Inc. | NxStage PureFlow-B Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125408 |
| mdprc 165 02 14 000 | Merit Medical Systems Inc | Procedure Trays, Merit Medical's Custom Procedural Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123393 |
| mdprc 148 02 14 000 | Bausch & Lomb Inc | AKREOS AO Micro Incision Lens | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125149 |
| mdprc 147 02 14 000 | Synthes Inc | Synthes Driving Cap/Threaded | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125106 |
| mdprc 146 02 14 000 | Medline Industries Inc | Guidewire .035x150 3MMJ TCFC used in a number of surgical convenience kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121458 |
| mdprc 145 02 14 000 | Terumo Cardiovascular Systems Corporation | VirtuoSaph Plus - Endoscopic Vessel Harvesting System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124916 |
| mdprc 144 02 14 000 | Smith & Nephew inc | Reflection(R) Interfit(TM) Shell, 52 MM OD, 3 HOLE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125406 |
| mdprc 137 02 14 000 | Perrigo Diabetes Care | Orbit soft Infusion sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124793 |
| mdprc 136 02 14 000 | Biocardia, Inc. | MORPH ACCESSPRO Steerable Introducer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125554 |
| mdprc 135 02 14 000 | The Standing Company | Superstand stand-up wheelchair HPS-2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124663 |
| mdprc 134 02 14 000 | Aesculap, Inc. | proSA Adjustment Disc Size Large (L) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124863 |
| mdprc 120 02 14 000 | Siemens Hearing Instruments, Inc | Siemens Prisma 2K Hearing Aid | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125067 |
| mdprc 099 02 14 000 | Medtronic Inc | Grafton DBM Flex Bone Graft Materials. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125127 |
| mdprc 091 02 14 000 | Boston Scientific | - Coyote MONORAIL PTA Balloon Dilatation Catheter
- 2.5mm Coyote OVERTHEWIRE PTA Balloon Dilation Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125452 |
| mdprc 089 02 14 000 | Tandem Diabetes Care, Inc | Syringes, t:slim Insulin Cartridges | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125111# |
| mdprc 073 02 14 000 | RTI Surgical, Inc | OPTEFORM Allograft Paste | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125083 |
| mdprc 072 02 14 000 | Integra LifeSciences | Malibu Polyaxial Screwdriver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125305 |
| mdprc 069 02 14 000 | OrthoPediatrics Corp | 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125200 |
| mdprc 068 02 14 000 | Stryker | Gaymar Medi-Therm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123805 |
| mdprc 067 02 14 000 | Ossur | The Symbionic Leg | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125089 |
| mdprc 046 02 14 000 | CareFusion | Trifurcated Extension Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125294 |
| mdprc 040 02 14 000 | Siemens Healthcare Diagnostics | -ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2pack
-ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124531
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124759 |
| mdprc 039 02 14 000 | B Braun Medical Inc. | AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124860 |
| mdprc 038 02 14 000 | Exactech | InteGrip Acetabular Augment | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125015 |
| mdprc 037 02 14 000 | Edwards Lifesciences | 26mm transcatheter heart valve crimper | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125336 |
| mdprc 034 02 14 000 | Horiba Instruments, Inc | ABX PENTRA N Control | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124157 |
| mdprc 033 02 14 000 | Medtronic Advanced Energy, LLC | Aquamantys3 Pump Generator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123689 |
| mdprc 031 02 14 000 | Merit Medical Systems Inc | Merit RAD BOARD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124977 |
| mdprc 029 02 14 000 | Synergetics Inc | Multiple illuminators & chandeliers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124930 |
| mdprc 028 02 14 000 | Boston Scientific Ltd | Atlantis PV 15 MHz Peripheral Imaging Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125181 |
| mdprc 026 02 14 000 | Carestream Health Inc | Carestream DRX Evolution System (Standard Q) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124636 |
| mdprc 025 02 14 000 | Philips Healthcare | Philips Brilliance CT system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122030 |
| mdprc 088 03 13 001 | Synthes Inc | Synthes Titanium Midface Distractor,osteotomy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115763 |
| mdprc 020 02 14 000 | Acute Innovations LLc | ACUTE Innovations Ribloc U plus Rib Fracture Plating System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124733 |
| mdprc 019 02 14 000 | Zimmer inc | Tapered ScrewVent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124976 |
| mdprc 018 02 14 000 | Kimberly-Clark Corporation | KimberlyClark RadiOpaque Radiofrequency Cannula | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123686 |
| mdprc 017 02 14 000 | Philips Healthcare | Brilliance iCT and iCT SP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125215 |
| mdprc 111 01 14 000 | Churchill Medical Systems | 7 Microbore Trifurcated Extension Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125099 |
| mdprc 110 01 14 000 | GE Healthcare | Vital Signs Breathing Circuits. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124805 |
| mdprc 109 01 14 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products COCM Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122450 |
| mdprc 108 01 14 000 | Bard Access Systems | -Titanium Single Lumen Low Profile port, with Pre-Attached Open-Ended Silicone 6.6Fr Catheter.
- MRI Low Profile Single Lumen port with OpenEnded 6.6Fr Silicone Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124442 |
| mdprc 107 01 14 000 | Navilyst Medical | Port Kit with Access Infusion Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124740 |
| mdprc 087 01 14 000 | Sorin Group | ORCHESTRA/ORCHESTRA PLUS Programmer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124518 |
| mdprc 079 01 14 000 | SpineFrontier Inc | Arena-L Trials (Handles and Heads) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121960 |
| mdprc 078 01 14 000 | Ranir Corporation | TopCare Clifford THE BIG RED DOG power toothbrush for kids and UP & UP kids power toothbrush | 1) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124742
2)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124741 |
| mdprc 077 01 14 000 | SIEMENS | SIMVIEW NT and SIMVIEW NT with IDI | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124791 |
| mdprc 063 01 14 000 | SIEMENS | Siemens syngo.plaza | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120166 |
| mdprc 062 01 14 000 | Vital Diagnostics, Inc. | Consult Diagnostics® Eon Calcium Reagent For In-Vitro Diagnostic Use | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122398 |
| mdprc 060 01 14 000 | GE Healthcare | Merge (Cedara) Mammo | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118680 |
| mdprc 058 01 14 000 | Zimmer inc | Palacos® R+G Radioplaque 1x40 g Single (with Gentamicin) Bone Cement | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124437 |
| mdprc 057 01 14 000 | The Anspach Effort, Inc. | Short Carbide Cutting Burs. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124773 |
| mdprc 052 01 14 000 | Midmark Corp | Vantage Panoramic X-Ray System firmware versions: 3.0, 3.1, 3.2, and 3.3. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122704 |
| mdprc 051 01 14 000 | Biomet Inc | Locking Cortical Screw 3.5mmX38mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124768 |
| mdprc 050 01 14 000 | The Anspach Effort, Inc. | Anspach MCA Cutting Burr | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124873 |
| mdprc 048 01 14 000 | King Systems Corp. | King Systems KLTSD414 airway | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124329 |
| mdprc 047 01 14 000 | Boston Scientific Ltd | Boston Scientific Extractor Pro XL Retrieval Balloon Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124763 |
| mdprc 035 01 14 000 | On Site Gas Systems Inc. | Portable Oxygen Generation System, POGS 33C | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124750 |
| mdprc 034 01 14 000 | Smiths Medical, Inc | Syringes,Smiths—29 G Hypodermic Needle-Pro Fixed Needle Insulin Syringes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124579 |
| mdprc 031 01 14 000 | Fresenius Medical Care | Hemodialysis Machines, 2008 Series | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122784 |
| mdprc 022 01 14 000 | RTI Surgical, Inc | Webless implants , C-Plus | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124694 |
| mdprc 020 01 14 000 | Materialise USA LLC | prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer, Signature | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124626 |
| mdprc 019 01 14 000 | SpineFrontier Inc | PedFuse Bone Probe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121928 |
| mdprc 018 01 14 000 | Trans American Medical, Inc | Wireless Footswitch/Handswitch system, Spectre | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121427 |
| mdprc 017 01 14 000 | Carestream Health Inc Div Onex Corp | DRX Revolution Mobile Xray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123275 |
| mdprc 016 01 14 000 | Aesculap | Aesculap Hi-Line XXS handpiece | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124615 |
| mdprc 015 01 14 000 | GE Healthcare | Centricity Laboratory System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117106 |
| mdprc 005 01 14 000 | Steris Corp | SYSTEM 1E Liquid Chemical Sterilant Processing System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124471 |
| mdprc 004 01 14 000 | Zimmer inc. | CPT Hip System, Trabecular Metal (TM) Reverse Glenosphere, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124349 |
| mdprc 003 01 14 000 | Merit Medical Systems Inc | Catheter, Maestro Microcatheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124756 |
| mdprc 194 12 13 000 | Terumo Cardiovascular Systems Corporation. | Valves, Overpressure Safety Valves Contained in Cardiovascular Procedure Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124644 |
| mdprc 193 12 13 000 | Philips Medical Systems | Monitor/Defibrillator, Philips HeartStart MRx | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124617 |
| mdprc 192 12 13 000 | Baxter Healthcare | Pharmacy Compounding Device (PCD), IntelliFill i.v. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124685 |
| mdprc 188 12 13 000 | SpineFrontier Inc | Indus Invue Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124182 |
| mdprc 186 12 13 000 | OrthoPediatrics Corp | ACL Reconstruction System Installation tools | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124474 |
| mdprc 185 12 13 000 | Philips Medical Systems | Monitor/Defibrillators, Philips HeartStart MRx | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124606 |
| mdprc 091 02 13 001 | Thermo Fisher Diagnostics | IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Legionella Species, Oxoid Legionella BCYE Growth Supplement Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114256 |
| mdprc 168 12 13 000 | SpineFrontier Inc | Reset Screw Inserters, PedFuse | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123912 |
| mdprc 167 12 13 000 | B Braun Medical Inc | Introcan Safety PUR Intravenous Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122558 |
| mdprc 166 12 13 000 | Integra LifeSciences | Monitors, Bedside, Intracranial Pressure , Integra Cranial Access Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124276 |
| mdprc 165 12 13 000 | CareFusion | Model 8000 and 8015 Alaris PC Unit Infusion Pump Systems. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123822 |
| mdprc 164 12 13 000 | Qualigen Inc | IVD : Immunoassay, FastPack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123729 |
| mdprc 163 12 13 000 | CooperVision Inc. | Contact lenses, Proclear & ClearSight | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124134
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124133 |
| mdprc 162 12 13 000 | ASI Medical, Inc | SEAC Advanced Dental System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124413 |
| mdprc 161 12 13 000 | SpineFrontier Inc | PedFuse Reset Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123002 |
| mdprc 160 12 13 000 | Arrow International Inc | Continuous Peropheral Nerve Block Catheter Kit and Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122660 |
| mdprc 149 12 13 000 | Hospira Inc | Infusion Pumps, SYMBIQ OneChannel and TwoChannel Infusers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121914 |
| mdprc 148 12 13 000 | Baxter Healthcare | Medical software, ABACUS TPN Calculation Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124436 |
| mdprc 147 12 13 000 | Remel Inc | IVD, Remel Streptex Group D Latex Reagents. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119040 |
| mdprc 146 12 13 000 | Remel Inc | IVD Test Reagent/Kits, Microbiology, Remel RapID Yeast Plus System Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119041 |
| mdprc 145 12 13 000 | Nephros Inc | Water purification, Nephros SafeSpout and SafeShower | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123218 |
| mdprc 127 12 13 000 | GE Healthcare | GE CO2 Multi Absorber Original, Disposable | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122872 |
| mdprc 119 12 13 000 | Aesculap Inc | Bipolar Coagulator, GNI161 Bipolar Foot Control | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122555 |
| mdprc 118 12 13 000 | Zimmer inc | Stemmed Tibial Component Precoat, NexGen Complete Knee Solutions | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123053 |
| mdprc 117 12 13 000 | Steris Corp | Steam sterilizer Transfer Carriage, AMSCO Evolution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123916 |
| mdprc 116 12 13 000 | Stryker Howmedica Osteonics Corp | Stryker cancellous Bone Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124144 |
| mdprc 101 12 13 000 | Zimmer inc | Trabecular Metal Total Ankle Tibial Base and Talus Components | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123120 |
| mdprc 100 12 13 000 | Synthes USA (HQ) Inc. | Trochanteric Fixation Nail | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122353 |
| mdprc 090 12 13 000 | Cutera Ltd | Massager, Vacuum, radio frequency induced heat, truSculpt infrared System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122929 |
| mdprc 087 12 13 000 | Synthes Inc | Nails, Bone , TFN Titanium Trochanteric Fixation Nail Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122361 |
| mdprc 086 12 13 000 | Centurion Medical Products | Rubber Bands, Centurion Sterile 84 Rubber Bands | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123693 |
| mdprc 085 12 13 000 | Karl Storz | Forceps, Axillent Debakey Grasping Forceps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123575 |
| mdprc 084 12 13 000 | Ethicon Endo Surgery Inc | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122798 |
| mdprc 177 08 13 001 | Zimmer inc | Implants , NexGen Complete Knee Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123523 |
| mdprc 083 12 13 000 | Synthes Inc | ZeroP VA Implant 7 MM Height Parallel Sterile | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122562 |
| mdprc 082 12 13 000 | GE Healthcare | Centricity Web Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117060 |
| mdprc 055 12 13 000 | Cincinnati Sub-Zero Products Inc | Data Export Software, Blanketrol III | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122858 |
| mdprc 053 12 13 000 | CareFusion | Low Sorbing Infusion Set with Texium Close Male Luer, SmartSite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123304 |
| mdprc 050 12 13 000 | CareFusion Inc, | Intravascular Administration Set, VersaSafe Extension Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123294 |
| mdprc 043 12 13 000 | Philips Healthcare | Universal Fluoroscopic applications, Easy Diagnost Eleva | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123097 |
| mdprc 017 12 13 000 | B Braun Medical Inc | Intravenous Fluid Containers, addEASE Binary Connectors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118620 |
| mdprc 016 12 13 000 | Ebi, Llc | Shortened Plug Driver, Biomet The Polaris Spinal SystemDriver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122904 |
| mdprc 015 12 13 000 | Synthes USA (HQ) Inc. | Synthes Vertebropasty Needle Kit 10g Diamond Tip | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122358 |
| mdprc 014 12 13 000 | Synthes USA (HQ) Inc. | Synthes 2.4 mm LCDCP Plate 6 Holes/51mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122357 |
| mdprc 013 12 13 000 | Synthes USA (HQ) Inc. | Synthes 4.5 mm LCP Curved Condylar Plate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122362 |
| mdprc 012 12 13 000 | Custom Ultrasonics, Inc | Endoscope Washer/Disinfector, Custom Ultrasonics System 83 Plus 2 and Plus 9 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121143 |
| mdprc 009 12 13 000 | Synthes Inc | 14.5 mm Outer Protection Sleeve for Suprapatellar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122646 |
| mdprc 008 12 13 000 | Lanx, Inc | Straight Split Tip Driver Short ( Driver ), Timberline MPF Lateral Modular Plate Fixation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123690 |
| mdprc 189 11 13 000 | Toshiba American Medical Systems Inc | Scanning Systems, Ultrasonic, Aplio XG and Xario XG Diagnostic Ultrasound Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121395 |
| mdprc 188 11 13 000 | Baxter Healthcare | VIAL-MATE Adapters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122241 |
| mdprc 175 11 13 000 | Synthes Inc | Tensioning Devices Used with Distraction Osteogenesis Ring Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122364 |
| mdprc 174 11 13 000 | Synthes Inc | Nails, Bone , Large Buttress Compression Nuts for Blade Guide Sleeve TFN Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122365 |
| mdprc 173 11 13 000 | Mindray DS USA, Inc., dba Datascope Patient Monitoring | Patient Monitor, V Series Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123285 |
| mdprc 170 11 13 000 | Biomet Inc | Carpal Tunnel Security Blades | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123472 |
| mdprc 169 11 13 000 | Mizuho | Mizuho Sugita Titanium Standard Aneurysm Clip II | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122611 |
| mdprc 165 11 13 000 | Ergosafe Products LLC | Total Support, patient stand, Medcare Products Max500 Stand | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121494 |
| mdprc 163 11 13 000 | Teleflex Medical | Disposable Metal Larynogoscope Blade, Green RuschLite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122874 |
| mdprc 155 11 13 000 | Biomet 3i Inc | Drill Bit, The Juggerknotless Soft Anchors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122873 |
| mdprc 154 11 13 000 | Stryker | Model FL14E Rose Beds | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121538 |
| mdprc 153 11 13 000 | EBI LP Sub Biomet Inc | Polaris Translation Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121961 |
| mdprc 152 11 13 000 | Wexford Labs | Ready-to-Use THYMO-CIDE Disinfectant Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122245 |
| mdprc 151 11 13 000 | Synthes Inc | Retractors, Orthopedic , Soft Tissue Retractors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122552 |
| mdprc 150 11 13 000 | Riverpoint Medical, LLC | PolyglycolicLactic Acid Absorbable Surgical Suture | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119650 |
| mdprc 149 11 13 000 | Candela Corporation | Candela Laser GentleLase Pro | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123370 |
| mdprc 148 11 13 000 | Spacelabs Healthcare Inc | Patient Monitor, qube Compact | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123184 |
| mdprc 147 11 13 000 | Trumpf Medical Systems, Inc. | Surgical Table, TruSystem | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122967 |
| mdprc 146 11 13 000 | Stryker Sustainability Solutions | Eletrophysiology Catheter; BARD,Daig,BW CristaCath,Response,Supreme,Qwik Cable,BW Webster, Carto 3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123045 |
| mdprc 015 09 13 001 | Zimmer inc | Distractors, Surgical, Shoulder , Trabecular Metal Reverse Glenosphere Distractor Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119862 |
| mdprc 097 08 13 001 | Zimmer inc | Trabecular Metal Reverse Glenosphere Helmets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119375 |
| mdprc 136 11 13 000 | Stryker | Acetabular Pressurizer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122400 |
| mdprc 135 11 13 000 | Beckman Coulter Inc | Access 2 Immunoassay System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122247 |
| mdprc 134 11 13 000 | SpineFrontier Inc | Extension Shims, S-LIFT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120086 |
| mdprc 133 11 13 000 | OrthoPediatrics Corp | 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122418 |
| mdprc 123 11 13 000 | Philips Medical Systems | Computed Tomography XRay System, Brilliance iCT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122697 |
| mdprc 122 11 13 000 | DeRoyal Industries Inc | Surgical Eye Spears | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122717 |
| mdprc 121 11 13 000 | ConMed Corporation | Thermal Tissue Fusion, ALTRUS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122579 |
| mdprc 120 11 13 000 | Carl Zeiss Meditec Inc | Ophthalmic device, IOLMaster | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122862 |
| mdprc 114 11 13 000 | The Anspach Effort, Inc. | BlackMax Motor Systems, MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, Emax2Plus M | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120536 |
| mdprc 113 11 13 000 | Integra LifeSciences | MAYFIELD Composite Series Skull Clamp | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122417 |
| mdprc 112 11 13 000 | GlaxoSmithKline | Biotene Moisturizing Mouth Spray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122970 |
| mdprc 094 11 13 000 | CareFusion.. | CareFusion Gravity Set , used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121572 |
| mdprc 087 11 13 000 | Mesa Laboratories, Inc | pH 7.0 Buffer Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122454 |
| mdprc 086 11 13 000 | Seppim | Calcium Arsenazo, CALA0250 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122064 |
| mdprc 085 11 13 000 | Pinook-Usa | Pinook Mini & Micro Massager | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122609 |
| mdprc 083 11 13 000 | Carestream Health Inc Div Onex Corp | DRX Revolution Mobile Xray System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121430 |
| mdprc 082 11 13 000 | Baxter Healthcare | Sigma Spectrum Infusion Pump component (LCD screen) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122243 |
| mdprc 081 11 13 000 | Urologix Inc | RF Therapy , Prostiva Hand Piece Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122692 |
| mdprc 079 11 13 000 | Spacelabs Healthcare Inc | Vital Signs Monitor, elance | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123183 |
| mdprc 078 11 13 000 | Fresenius Medical Care | Combiset Bloodlines | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121293 |
| mdprc 077 11 13 000 | Baxter Healthcare | SIGMA SPECTRUM Infusion Pumps with Master Drug Library | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121520 |
| mdprc 075 11 13 000 | St. Jude Medical Inc. | Safire Duo Ablation Catheter MediGuide Enabled | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122638 |
| mdprc 060 11 13 000 | Ethicon Inc | Gastroplasty Bands , REALIZE Adjustable Straight Gastric Bands | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122437 |
| mdprc 059 11 13 000 | Handicare Ltd | Bath Lifts , Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114924 |
| mdprc 058 11 13 000 | Baxter Healthcare. | Dual Luer Lock Caps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121842 |
| mdprc 057 11 13 000 | Steris Corp | Equipment Management System, Harmony | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121539 |
| mdprc 056 11 13 000 | St. Jude Medical Inc. | US Safire Duo Ablation Catheter MediGuide Enabled, Cool Path Duo Ablation Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122676 |
| mdprc 055 11 13 000 | Smiths Medical | Spinal Anesthesia Trays, Portex | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122134 |
| mdprc 054 11 13 000 | Insulet Corporation | Insulin Management System Starter Kit & Demonstration Kit, OmniPod | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122397 |
| mdprc 044 11 13 000 | Richard Wolf | S(a)line resectoscopes BiPolar Vaporization Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122427 |
| mdprc 043 11 13 000 | Insight Instruments Inc | Ophthalmic singleport illumination, MLS Torpedo MiniLight | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121305 |
| mdprc 042 11 13 000 | Bayer Healthcare LLC | A1cNow+ Multi-Test A1c System 20-Test Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121482 |
| mdprc 041 11 13 000 | Edwards Lifesciences | Duraflo coated Dispersion Tip Arterial Cannulae & coated FemFlex Arterial Cannula | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121500 |
| mdprc 037 11 13 000 | Smith & Nephew | NONPOROUS TIBIAL BASE, GENESIS(R) SIZE 6, RIGHT & SIZE 5, LEFT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122572 |
| mdprc 036 11 13 000 | EKOS Corp | EKOS EkoSonic Control Unit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122511 |
| mdprc 034 11 13 000 | Baylis Medical Corp | Transseptal Guiding Sheath, TorFlex | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122172 |
| mdprc 019 11 13 000 | Zimmer inc | Femoral Fixation System S/C Plates, Ti-Magna Fx Washer, Ti-Versa FX II | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121736 |
| mdprc 018 11 13 000 | Medtronic Neuromodulation | Various Implantable Neurostimulators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122448 |
| mdprc 016 11 13 000 | Carestream Health Inc. | Radiographic Units, Mobile, DRX-Revolution Mobile X-Ray Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119661 |
| mdprc 012 11 13 000 | Carestream Health Inc. | DRX Revolution Mobile XRay System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120273 |
| mdprc 009 11 13 000 | Carestream Health Inc Div Onex Corp | DRX-Revolution Mobile X-Ray Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119011 |
| mdprc 007 11 13 000 | Globus Medical, Inc | MicroFuse Bone Void Filler | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121916 |
| mdprc 106 05 13 002 | Merit Medical Systems Inc | Performa® Cardiac Multipack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122251 |
| mdprc 151 10 13 000 | Atossa Genetics, Inc | ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122387 |
| mdprc 149 10 13 000 | Depuy Orthopaedics | Medium Viscosity Antibiotic Bone Cement, SmartSet GMV Endurance | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121889 |
| mdprc 148 10 13 000 | SIEMENS | Imaging ultrasound systems, Acuson SC2000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120286 |
| mdprc 141 10 13 000 | DeVilbiss Healthcare LLC | Suction Unit , DeVilbiss Vacu-Aide QSU ,(Disposable Suction Container/Filter), 800 ML | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122122 |
| mdprc 140 10 13 000 | Sysmex America Inc | Automated Hematology Analyzer , pocH-100i | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119961 |
| mdprc 139 10 13 000 | Aesculap | Surgical Instruments , supported arm , UNITRAC Pneumatic Retraction Arm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121001 |
| mdprc 138 10 13 000 | Convergent Dental | Laser Surgical instrument , Solea 1.0 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122154 |
| mdprc 093 10 13 000 | SonoSite Inc | Transducer , P21x/5-1 MHz | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122088 |
| mdprc 092 10 13 000 | Opti Medical Systems Inc | IVD , OPTIMedical Cassettes , | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121489 |
| mdprc 089 10 13 000 | Siemens Healthcare Diagnostics Inc | IVD ,reagent , Dimension Vista | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117107 |
| mdprc 088 10 13 000 | Sekisui Diagnostics | OSOM BVBlue Rapid Test Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121955 |
| mdprc 087 10 13 000 | Harvest Healthcare | Delivery System , Harvest Graft | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121918 |
| mdprc 065 10 13 000 | Bard Pcripheral Vascular (BPV) | LIFESTENT Solo Vascular Stent Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122212 |
| mdprc 057 10 13 000 | Maquet Cardiopulmonary AG | Cardiac surgery instruments , Ultima OPCAB System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122158 |
| mdprc 055 10 13 000 | Instrumentation Laboratory | Coagulation, reagent, HemosIL RecombiPlasTin 2G | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118777 |
| mdprc 133 02 13 001 | CareFusion | SmartSite®® Gravity Blood Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115553 |
| mdprc 045 10 13 000 | AMS Innovative Center - San Jose. | Laser Delivery Systems, Fiberoptic, GreenLight HPS and XPS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115154 |
| mdprc 026 10 13 000 | Mckesson Information Solutions LLC | Radiological Image Processing System , Horizon Medical Imaging | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121962 |
| mdprc 025 10 13 000 | Hologic Inc | Digital Mammography System , Selenia | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121704 |
| mdprc 024 10 13 000 | ASO, LLC | Waterproof Adhesive Pads Antibacterial , SHOPKO | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122141 |
| mdprc 023 10 13 000 | H and H Medical Corp | Emergency Cricothyrotomy Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121529 |
| mdprc 014 10 13 000 | Synthes USA (HQ) Inc | Distal Humerus System , Synthes 3.5 MM LCP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117661 |
| mdprc 013 10 13 000 | King Systems Corp. | Breathing Circuit , Universal Flex2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121659 |
| mdprc 004 10 13 000 | Synthes USA (HQ) Inc. | Vertebral body replacement device , Oracle Spacer System Slap Hammer . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115645 |
| mdprc 003 10 13 000 | Spine Smith Holdings, LLC | Medical apparatus , spinal fusion devices , VISUALIF | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121169 |
| mdprc 001 10 13 000 | CareFusion | Infusion Set , SmartSite Low Sorbing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121570 |
| mdprc 116 09 13 000 | Smiths Medical ASD Inc. | PORT-A-CATH and PORT-A-CATH II Implantable Venous Access Systems Introducer Sets. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121805 |
| mdprc 115 09 13 000 | Microgenics Corp | IVD , DRI Cocaine Metabolite Assay labeled as Multigent Cocaine Assay for Abbott Laboratories | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120699 |
| mdprc 114 09 13 000 | Maquet Cardiopulmonary AG | QUADROX Oxygenators, Holding Clamps, and Tubing Pack Products | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121375 |
| mdprc 113 09 13 000 | Invacare Corporation | Power Wheelchair , Invacare . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118605 |
| mdprc 112 09 13 000 | Endoplus, Inc. | Precision Laparoscopic Instruments , Endoplus Single Action Insert | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121426 |
| mdprc 106 09 13 000 | GE Healthcare | X-Ray Imaging System , Discovery IGS 730 Cardiovascular | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121602 |
| mdprc 105 09 13 000 | Access Scientific Inc | Catheter , POWERWAND Safety Introducer with Extended Dwell Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121781 |
| mdprc 104 09 13 000 | Rauland-Borg Corp | Nurse call communication system , Responder 5 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119829 |
| mdprc 103 09 13 000 | Cincinnati Sub-Zero Products Inc | Hyper/Hypothermia System , Blanketrol III | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121580 |
| mdprc 014 01 13 001 | Hill Rom Inc | Liko Standard Slingbar 450 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110438 |
| mdprc 091 09 13 000 | Villa Radiology Systems LLC | Juno DRF System. Mobile X-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121286 |
| mdprc 090 09 13 000 | Medtronic Sofamor Danek USA Inc | Removal driver, T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121220 |
| mdprc 089 09 13 000 | Assuramed | IVD ,ProTime Microcoagulation System,DiaScreen Liquid Urine Controls, Hemoccult II SENSA elite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121133 |
| mdprc 088 09 13 000 | Lumenis Inc | Vision One Laser System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121534 |
| mdprc 087 09 13 000 | Edwards Lifesciences | Sensor , single use kit , FloTrac Sensor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121142 |
| mdprc 086 09 13 000 | CareFusion | Thoracentesis and Safe-T Thoracentesis Drug-Free Trays. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121524 |
| mdprc 085 09 13 000 | Cardiogenesis Corporation | handpieces , fiberoptics , Cardiogenesis Transmyocardial the SoloGrip III (HP-5G3) and the PEARL 5.0 (HP-PRL5). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121314 |
| mdprc 061 09 13 000 | Roche Diagnostics Ltd | IVD , KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121300 |
| mdprc 060 09 13 000 | Covidien LLC | Flush syringe , Monoject | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121123 |
| mdprc 056 09 13 000 | Berchtold Corp | Surgical Table , D850 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121072 |
| mdprc 050 09 13 000 | Baxa Corp | Vial Adapter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121455 |
| mdprc 049 09 13 000 | B Braun Medical Inc | Infusion System , Outlook Safety Infusion System Burette Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121164 |
| mdprc 042 09 13 000 | Stelkast Co | Distal Femoral Augment with Screw , SC2316 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120308 |
| mdprc 041 09 13 000 | MicroAire Surgical Instruments | K-Wire and Steinmann Pin Products | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121296 |
| mdprc 032 09 13 000 | Roche Diagnostics Ltd | B-CrossLaps/serum ,ELECSYS®-CrossLaps/Serum Immunoassay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118059 |
| mdprc 025 09 13 000 | SpineNet | SpineNet Anterior Cervical Cage , Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120864 |
| mdprc 024 09 13 000 | SpineNet | SpineNet Anterior Cervical Cage , Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120864 |
| mdprc 023 09 13 000 | SIEMENS | C-arm angiographic x-ray system , Axiom Artis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120167 |
| mdprc 022 09 13 000 | Medtronic Inc Cardiac Rhythm Disease Management Div | perfusion systems , Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120358 |
| mdprc 021 09 13 000 | DeRoyal Industries Inc | Laparoscopic , Insufflation Tubing sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120078 |
| mdprc 020 09 13 000 | Alphatec Spine Inc | Screw , lllico Ti Cannulated Polyaxial Screw 7.5mm X 40mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119844 |
| mdprc 019 09 13 000 | 3M Company / Medical Division | Crown , Unitek Primary Stainless Steel Crowns | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120837 |
| mdprc 014 09 13 000 | Zimmer inc | Femoral Hip , Free Lock Femoral Fixation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120083 |
| mdprc 013 09 13 000 | Synthes Inc | Plates, Bone, 2.4 mm VA-LCP 2-Column Volar Distal Radius Plates Used with 1.2 Nm Torque-Limiting Attachment | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119565 |
| mdprc 012 09 13 000 | Synthes USA (HQ) Inc. | Plate , Bone , Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120724 |
| mdprc 008 09 13 000 | Philips Healthcare | Radiographic system , Philips Easy Upgrade DR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120999 |
| mdprc 007 09 13 000 | Mckesson Information Solutions LLC | Anesthesia , Mc Kesson Anesthesia | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120087 |
| mdprc 006 09 13 000 | Life Technologies Corporation | IVD , Reagents , HSV-2 Primers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120130 |
| mdprc 005 09 13 000 | Integra LifeSciences | Clamps, Skull, Leyla Ball Joint Clamps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120309 |
| mdprc 004 09 13 000 | Fresenius Medical Care | Pump , 2008 MeDS Pump, Venofer(R) Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117850 |
| mdprc 006 02 13 001 | Ethicon Endo Surgery Inc | The ENSEAL® G2 Tissue Sealers ,Electrosurgical Units | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115291 |
| mdprc 175 08 13 000 | Micro Therapeutics Inc | Catheter , endovascular treatment, Pipeline Embolization Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120283 |
| mdprc 174 08 13 000 | GE Healthcare | Computed Tomography X-ray System , LightSpeed CT750 HD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118572 |
| mdprc 162 08 13 000 | Stryker Communications | Lights, Examination, Visum 300 Ceiling - Mounted Examination Lights | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120723 |
| mdprc 161 08 13 000 | Philips Healthcare | Radiography, MobileDiagnostwDR system, ile Digital radiography X-Ray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120442 |
| mdprc 160 08 13 000 | Getinge Disinfection AB | Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121®C, 132®C, 134®C and 135®C steam sterilization cycles. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120574 |
| mdprc 159 08 13 000 | Blue Belt Technologies | Monitor Drape REF: PFSD-V0001, Rx only, Sterile | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120387 |
| mdprc 154 08 13 000 | Medicel AG | Injector System, nanoPOINT Injector System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120811 |
| mdprc 153 08 13 000 | Sorin Group | Edwards Lifesciences Suction Wand , packaged in Sorin Group Heart/Lung Perfusion Packs. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120616 |
| mdprc 152 08 13 000 | Atrium Medical Corporation | PleuraGuide Disposable Chest Tube Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119863 |
| mdprc 151 08 13 000 | GE Healthcare | The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120193 |
| mdprc 150 08 13 000 | Aspen Surgical Products, Inc. | Reinforced Wound Closure | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120111 |
| mdprc 144 08 13 000 | Gyrus ACMI | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120141 |
| mdprc 142 08 13 000 | Zimmer inc | Prostheses,Moore Long Fenestrated Stem Hip Prostheses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120360 |
| mdprc 141 08 13 000 | Terumo Cardiovascular Systems Corporation | Heart-Lung Bypass Units , Advanced Perfusion System 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119873 |
| mdprc 140 08 13 000 | Endogastric Solutions Inc | Prostheses, Gastroesophageal, Antireflux, EsophyX2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120509 |
| mdprc 139 08 13 000 | Boston Scientific Cardiac Rhythm Management Group | Cardioverter Defibrillator. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120194 |
| mdprc 138 08 13 000 | SIEMENS | Fluoroscopic X-Ray system , Luminos dRF | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119218 |
| mdprc 137 08 13 000 | Siemens Medical Solutions | Linear accelerators, Siemens ARTISTE, ONCOR and PRIMUS systems. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117486 |
| mdprc 131 08 13 000 | Terumo Cardiovascular Systems Corporation | Pumps, Extracorporeal Perfusion, Heart-Lung Bypass Units, Advanced Perfusion System 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119861 |
| mdprc 130 08 13 000 | Terumo Cardiovascular Systems Corporation | Advanced Perfusion System 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118618 |
| mdprc 129 08 13 000 | Medtronic Inc Cardiac Rhythm Disease Management Div | Pediatric filter , Affinity Pediatric Arterial Filter, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119981 |
| mdprc 128 08 13 000 | Epocal Inc | IVD , epoc BGEM Test Card | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117928 |
| mdprc 127 08 13 000 | Arrow International Inc | Catheter , Arrow Two-Lumen CVC Kit with Blue Flex Tip Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120336 |
| mdprc 099 08 13 000 | SpineFrontier Inc | Screwdriver , Tipped Tapered Solid Driver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117613 |
| mdprc 098 08 13 000 | SpineFrontier Inc | Surgical instruments , Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117565 |
| mdprc 090 08 13 000 | Synthes Inc | Pedicle screw spinal system , USS Small Stature | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119580 |
| mdprc 089 08 13 000 | SIEMENS | Angiographic system , AXIOM Artis zeego x-ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119960 |
| mdprc 088 08 13 000 | OrthoPediatrics Corp | OrthoPediatrics PediLoc Locking Plate System , 3.2mm Drill Bit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120334 |
| mdprc 087 08 13 000 | Nova Biomedical Corporation | Nova Max Glucose Test Strips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120658 |
| mdprc 086 08 13 000 | Medtronic Xomed Inc | Tray Surgical , ENT ( various instrument trays ) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120407 |
| mdprc 085 08 13 000 | GE Healthcare | UltraSound Imaging , LOGIQ S8 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119647 |
| mdprc 078 08 13 000 | SpineFrontier Inc | T-Handle, Strike Plate, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117599 |
| mdprc 077 08 13 000 | SpineFrontier Inc | Spinal fusion , Invue Split Driver, Assembly with Handle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119841 |
| mdprc 076 08 13 000 | SpineFrontier Inc | Screw , Indus Invue Screw Caddy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119818 |
| mdprc 075 08 13 000 | SpineFrontier Inc | Screw inserter (screwdriver - orthopedic manual surgical instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117582 |
| mdprc 074 08 13 000 | Mitsubishi Heavy Industries Ltd. | Radiation therapy , MHI-TM2000 Linear Accelerator System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120158 |
| mdprc 073 08 13 000 | Aspen Surgical Products, Inc. | Surgical Tape Strips , Meijer Wound Closure Adhesive Surgical Tape Strips , Walgreens ("W" and "Well at Walgreens") , Duane Reade (DR) , Premier Value , Discount Drug Mart , TopCare , HEB , Leader | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120302 |
| mdprc 072 08 13 000 | American Optisurgical Inc | Hand pieces, Surgical, TX1 Tissue Removal System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107666 |
| mdprc 049 08 13 000 | SIEMENS | Imaging , mobile X-ray , MIRA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119699 |
| mdprc 048 08 13 000 | Hospira Inc | IVD sets , Blood Set , Y-Type Blood Set , Plum Blood Set , Secondary Blood Set . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119891 |
| mdprc 044 08 13 000 | SpineFrontier Inc | Drill Guide (guide, surgical, instrument) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117583 |
| mdprc 043 08 13 000 | Precision Medical. | Non-sterile Viscot Surgical Skin Markers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119963 |
| mdprc 031 08 13 000 | Wako Chemicals | Reagent cartridge , uTASWako DCP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117873 |
| mdprc 030 08 13 000 | Tosoh Corporation | IVD , Analyzer, AIA Analyzer Pipette | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119615 |
| mdprc 029 08 13 000 | SpineFrontier Inc | S-LIFT Slap Hammer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117721 |
| mdprc 028 08 13 000 | SpineFrontier Inc | Caddy - PedFuse, Screw Caddy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117585 |
| mdprc 027 08 13 000 | SIEMENS | Picture Archiving and Communication, Radiology , syngo Dynamics Information System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119697 |
| mdprc 026 08 13 000 | GE Healthcare | Ultrasound System., LOGIQ e | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120062 |
| mdprc 025 08 13 000 | GE Medical Systems | Ultrasound Systems , VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120056 |
| mdprc 024 08 13 000 | Exactech | Non powered hand-held device , Articulated Driver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119601 |
| mdprc 023 08 13 000 | Accelerated Care Plus Corporation | powered exercise equipment intended for medical purposes , Omnicycle Elite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119317 |
| mdprc 019 08 13 000 | Synthes USA (HQ) Inc. | Drill Guide , Synthes Synapse SD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119839 |
| mdprc 018 08 13 000 | Synthes USA (HQ) Inc. | Synthes Large External Fixation, MR Conditional | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119840 |
| mdprc 017 08 13 000 | Stryker | CORE and RenB Universal Drivers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118956 |
| mdprc 015 08 13 000 | Steritec Products Mfc | Cardinal BI Stat Biological Test Pack with Instant Readout Integrator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119713 |
| mdprc 012 08 13 000 | Custom Spine, Inc | Spinal Fixation System , Custom Spine ISSYS LP Inverted Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117828 |
| mdprc 202 07 13 000 | Aesculap | Aesculap PEEK Intervertebral Body Fusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119939 |
| mdprc 201 07 13 000 | SIEMENS | AXIOM Aristos MX X-Ray Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119698 |
| mdprc 200 07 13 000 | Haemonetics Corp | IVD , Coagulation Analyzer , Thromboelastograph Instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119790 |
| mdprc 198 07 13 000 | Church & Dwight Inc | Sodium Bicarbonate, USP Provided bulk as raw material | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119877 |
| mdprc 197 07 13 000 | Becton Dickinson & Co. (BD) | IVD , BD Affirm VPIII Microbial Identification Tests | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119730 |
| mdprc 181 07 13 000 | St. Jude Medical Inc | Charging System , Eon - 3701 (Wall Charger) and 3711 (Portable Charger) , Eon Mini - 3721 (Charger). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115091 |
| mdprc 180 07 13 000 | Steris Corporation | STERIS Fine Traction Device , used to to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119612 |
| mdprc 179 07 13 000 | SIEMENS | Angiograph , Artis zee / zeego | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119815 |
| mdprc 178 07 13 000 | Pemco Inc | Surgical retractor , Rultract Retractor Ratchet Cover Plate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119864 |
| mdprc 177 07 13 000 | Hill Rom Inc | Beds, AccuMax Quantum Mattresses Used with TotalCare Bed Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118400 |
| mdprc 175 07 13 000 | Cardio Medical Products | ECG Electrode , Cardio Medical Products | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118978 |
| mdprc 167 07 13 000 | Myoscience Inc | A Cryogenic Surgical device, iovera | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119527 |
| mdprc 163 07 13 000 | Synthes Inc | Multi Vector Distractor Pin Holding Clamp | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119576 |
| mdprc 162 07 13 000 | Staar Surgical Co | Intracellular lens , NanoFLEX CC4204A | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119567 |
| mdprc 161 07 13 000 | SpineFrontier Inc | Screw , spinal system , Rods - Pedicle screw spinal system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117587 |
| mdprc 160 07 13 000 | Physio Control Inc | Defibrillator , LIFEPAK 500 Automated External | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119584 |
| mdprc 159 07 13 000 | Philips Healthcare | Monitors, Central Station, IntelliVue Smart-Hopping | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119750 |
| mdprc 158 07 13 000 | Integra LifeSciences Corporation | Nail systems , PANTA Arthrodesis Nail Support Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118787 |
| mdprc 157 07 13 000 | Carl Zeiss Meditec Inc | Diagnosis by color variation , , Polarizer D Fixed w/Rotating Red 1 lambda plate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118619 |
| mdprc 155 07 13 000 | Boston Scientific Corporation | Catheter , Alair Bronchial Thermoplasty Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118510 |
| mdprc 154 07 13 000 | Baxter Healthcare | EXACTAMIX Compounders with DY Display Modules | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118289 |
| mdprc 121 06 13 001 | Respironics Inc | Ventilators, V60 Ventilator | FDA |
| mdprc 125 07 13 000 | Biomet Inc | Oxford Fixed Bearing Partial Knee Replacement , Cemented Lateral Tibia | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119065 |
| mdprc 123 07 13 000 | Terumo Cardiovascular Systems Corporation | Blood Parameter Monitoring System , CDI 500 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105527 |
| mdprc 122 07 13 000 | Synthes Inc | Synthes CMF Distraction System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119842 |
| mdprc 121 07 13 000 | SagaTech Electronics, Inc. | Sleep recorder , Remmers (formerly SnoreSat) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119816 |
| mdprc 120 07 13 000 | KooJoo Trading Company | Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119830 |
| mdprc 119 07 13 000 | Karl Storz Endoscopy UK Ltd | 27023WU Balloon Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119378 |
| mdprc 118 07 13 000 | Fresenius Medical Care | Hemodialysis machines , Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117864 |
| mdprc 117 07 13 000 | DeRoyal Industries Inc | General surgical used , GEO-MED ORTHO TOTAL JOINT TRACECART® , | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119554 |
| mdprc 149 04 12 001 | Leica Microsystem inc | Laboratory Instrument, ASP 6025 Vaccum Tissue Processor | FDA |
| mdprc 103 07 13 000 | Zimmer inc | Orthopaedic , Bigliani/Flatow® The Complete Shoulder Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118471 |
| mdprc 102 07 13 000 | Toshiba American Medical Systems Inc | X-ray , TOSHIBA Kalare Diagnostic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117798 |
| mdprc 101 07 13 000 | Medtronic MiniMed | Insulin Infusion Sets , Medtronic MiniMed Paradigm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118883 |
| mdprc 100 07 13 000 | Fresenius Medical Care | Dialysis System , Fresenius | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118571 |
| mdprc 098 07 13 000 | Baxter Healthcare | Irrigation Set , Four Lead TUR Irrigation Set, UROMATIC Plastic Containers , Four Lead Arthroscopic irrigation Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118153 |
| mdprc 094 07 13 000 | Baxter Healthcare. | Elastomeric infusion pumps , FOLFUSOR , INFUSOR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119649 |
| mdprc 021 07 13 001 | GE Healthcare | Radiographic Systems, GE Healthcare Senographe Essential System | FDA |
| mdprc 072 05 12 001 | Zimmer inc | Nexgen Complete Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108582 |
| mdprc 081 07 13 000 | Bryan Medical Inc | Pediatric tracheostomy tube , Tracoe Mini 3.0mm Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118949 |
| mdprc 055 07 13 000 | SpineFrontier Inc | Intervertebral Body Fusion Device , S-LIFT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118893 |
| mdprc 054 07 13 000 | SpineFrontier Inc | Inserter , InSpan Inserter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118935 |
| mdprc 053 07 13 000 | SpineFrontier Inc | Fixation , S-LIFT inserter outer sleeve | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118885 |
| mdprc 044 07 13 000 | Merit Medical Systems Inc | Angiography Kits, Custom Procedural Trays | FDA |
| mdprc 042 07 13 000 | BRAEMAR, INC. | Lithium Thionyl non-rechargeable disposable battery pack | FDA |
| mdprc 041 07 13 000 | BRAEMAR, INC. | Lithium Thionyl non-rechargeable disposable battery pack | FDA |
| mdprc 040 07 13 000 | ConMed Linvatec Corporation | Soft-tissue anchor, GENESYS Cross FT Suture Anchor with Two #2 (5 metric) HI-FI Sutures | FDA |
| mdprc 039 07 13 000 | Clorox Healthcare Holdings, LLC (dba HealthLink) | Punches, Biopsy, Skin, Disposable, Biopsy Punches | FDA |
| mdprc 038 07 13 000 | Surgical Instrument Service And Savings, Inc. | Surgical instrument, Various products | FDA |
| mdprc 027 07 13 000 | Bard Access Systems | Catheter Tube Holders, StatLock | FDA |
| mdprc 026 07 13 000 | GE Healthcare | X-ray, GE Healthcare, Innova 3100 and Innova 4100 systems | FDA |
| mdprc 025 07 13 000 | Baxter Healthcare | Infusion Pumps, Coiled Tube Infusor, Infusion Pump | FDA |
| mdprc 024 07 13 000 | Terumo Medical Corporation | Catheter accessories, Terumo Glidesheath and Pinnacle® Destination® Peripheral Guiding Sheath | FDA |
| mdprc 023 07 13 000 | RF Technologies, Inc. | Fall Management Solutions, Code Alert, Sensatec | FDA |
| mdprc 022 07 13 000 | Steris Corp | Sterilization device accessories, Quick Connect | FDA |
| mdprc 020 07 13 000 | Cynosure | Lasers, RevLite SI Laser | FDA |
| mdprc 019 07 13 000 | ThermoFisher Scientific | Incubators, Laboratory, Thermocycling, CO2 Incubators (General Purpose Incubator) | FDA |
| mdprc 018 07 13 000 | Engineered Medical Systems,Inc | Masks, SealFlex | FDA |
| mdprc 077 05 13 001 | Hologic Inc | Imaging System, Fluoroscan Mini C-arm InSight2, | FDA |
| mdprc 150 06 13 000 | Philips Healthcare | X-ray, Philips Bucky Diagnost | FDA |
| mdprc 149 06 13 000 | Philips Healthcare | X-ray, Philips Bucky Diagnost | FDA |
| mdprc 148 06 13 000 | Medtronic Sofamor Danek USA Inc | Grafts, Bone, INFUSE(R) Bone Graft | FDA |
| mdprc 147 06 13 000 | Medrad Inc | Monitors, Physiologic, Vital Signs, DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor | FDA |
| mdprc 146 06 13 000 | Zimmer inc | Surgical Instruments, Drill, NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm | FDA |
| mdprc 145 06 13 000 | GE Healthcare | Information system, Centricity Laboratory Core Lab | FDA |
| mdprc 129 06 13 000 | Prism Medical Ltd | Lifts, Patient Transfer, C-Series Carry Bar | FDA |
| mdprc 128 06 13 000 | Terumo Cardiovascular Systems Corporation | Heat Exchangers, Sarns " TCM II Temperature Control Module | FDA |
| mdprc 127 06 13 000 | Microgenics Corp | Reagent, Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems | FDA |
| mdprc 126 06 13 000 | Linde Gas North America Llc | Portable Oxygen System, MEDICYCL-E- Lite | FDA |
| mdprc 125 06 13 000 | Tecan US | Automation Systems, Laboratory, Freedom EVO 2 with TouchTools Suite Version 3.0 | FDA |
| mdprc 124 06 13 000 | Hitachi Medical Corp | MR imaging device systems, Echelon, Echelon Oval and Oasis | FDA |
| mdprc 123 06 13 000 | Prism Medical Ltd | Mesh Sling, BC Hammock | FDA |
| mdprc 122 06 13 000 | Ortho-Clinical Diagnostics | IVD, VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent | FDA |
| mdprc 120 06 13 000 | Biomet Inc | Connecting Bolt Trauma Fixation Systems, Phoenix Retrograde Femoral Nail | FDA |
| mdprc 019 04 12 001 | IDEV Technologies Inc | SUPERA VERITAS Interwoven Nitinol Stent Transhepatic Biliary Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107279 |
| mdprc 114 06 13 000 | Zimmer inc | Frames, Traction, Zimmer Patient Helper Bed Frame Adapter Assembly | FDA |
| mdprc 113 06 13 000 | Ormco/Sybronendo | Dental Hand Instruments, Endodontic, SybronEndo Elements Obturation Unit and SybronEndo Replacement AC Power Cord, US Elements Obturation | FDA |
| mdprc 112 06 13 000 | Utah Medical Products, Inc | Transducers, Pressure, Disposable, Deltran Kit | FDA |
| mdprc 111 06 13 000 | Embla System Llc | Polysomnography Recorder, Ventilator Effort Recorder, Embletta Gold | FDA |
| mdprc 110 06 13 000 | Leica Microsystems, Inc. | Storage device, LPC Fine Mesh Cassettes | FDA |
| mdprc 108 06 13 000 | Philips Healthcare | Radiographic System , Philips Digital Diagnostic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115400 |
| mdprc 107 06 13 000 | Philips Healthcare | Radiographic System , Philips Digital Diagnost | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115398 |
| mdprc 106 06 13 000 | Biomet Inc | Comprehensive reverse shoulder system , Superior Approach Resection Guide Assembly | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118271 |
| mdprc 082 08 12 001 | Epocal Inc | Reagents, epoc BGEM Test Cards Used with epoc Blood Analysis Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107399 |
| mdprc 067 06 13 000 | Bard Pcripheral Vascular (BPV) | Implantable, Catheter, Guiding, Vascular, BARD Biopsy Systems and support catheters (Microsheath and Usher) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115745 |
| mdprc 065 06 13 000 | Endologix Inc | Catheter, Introducer, AFX Introducer System | FDA |
| mdprc 064 06 13 000 | Invatec SpA | Catheter, lnvatec SpA brand Diver C.E | FDA |
| mdprc 063 06 13 000 | Bard Pcripheral Vascular (BPV) | Markers, Implantable Radiographic, UltraClip Dual Trigger breast tissue marker | FDA |
| mdprc 062 06 13 000 | Fenwal | Apheresis Unit, AMICUS Exchange Kit | FDA |
| mdprc 061 06 13 000 | American Optisurgical Inc | Handpieces, Surgical, TX1 Tissue Removal System | FDA |
| mdprc 060 06 13 000 | Cordis Corporation | Stents, Vascular, Peripheral, Self-Expanding, FLEXSTENT | FDA |
| mdprc 092 03 13 001 | Symbios Medical Products | Elastometric infusion PumpKit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116110 |
| mdprc 050 06 13 000 | SpineFrontier Inc | Surgical instruments, implant impactor, Dorado Straight Impactor | FDA |
| mdprc 049 06 13 000 | Kreg Medical Inc. | Beds, Electric, EZ Wider Bariatric Bed | FDA |
| mdprc 048 06 13 000 | Stryker Instruments | Gowns, Medical, Hytrel Toga | FDA |
| mdprc 047 06 13 000 | Coloplast A/S | Suture, Digitex 2-0 Polydioxanone (PDO) suture | FDA |
| mdprc 046 06 13 000 | Biomet Inc | Prostheses, Joint, Hip, E1 Advantage Head | FDA |
| mdprc 045 06 13 000 | Zimmer Surgical Inc | Dermatomes, Manual, Air Dermatome | FDA |
| mdprc 044 06 13 000 | Hill Rom Inc | Beds, Electric, Hill-Rom 1000 Bed | FDA |
| mdprc 043 06 13 000 | Hill Rom Inc | Lifts, Patient Transfer, SlingBar | FDA |
| mdprc 042 06 13 000 | HORIBA ABX Diagnostics | IVD, measure absorbance and ion electrodes, ABX PENTRA 400 I.S.E. Module | FDA |
| mdprc 024 06 13 000 | Maytex Corp | Mask, Comfort Ear-Loop Face Mask | FDA |
| mdprc 023 06 13 000 | GE Healthcare | Various Anesthesia Machines, Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems | FDA |
| mdprc 022 06 13 000 | I-Flow | Infusion Pump Administration Sets, I-Flow ON-Q Pain Relief System | FDA |
| mdprc 021 06 13 000 | Gyrus ACMI | Knife, Blade, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE | FDA |
| mdprc 020 06 13 000 | Heart Sync, Inc | Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes, Vermed, Inc & Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes | FDA |
| mdprc 019 06 13 000 | TZ Medical Inc. | Adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Medtronic/Physio Control Transparent Defibrillation Electrodes | FDA |
| mdprc 015 06 13 000 | Fisher & Paykel Healthcare Inc | Therapeutic positive pressure breathing ventilator, Fisher & Paykel Healthcare ICON CPAP | FDA |
| mdprc 014 06 13 000 | Intuitive Surgical Inc | Telemanipulation Systems, Surgical, Minimally Invasive, daVinci TORS | FDA |
| mdprc 108 05 13 000 | Separation Technology, Inc | SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE | FDA |
| mdprc 107 05 13 000 | Polymer Technology Systems, Inc. | IVD,CardioChek PTS Panels Glucose Test Strips | FDA |
| mdprc 097 05 13 000 | Unimed Surgical Products, Inc | PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm | FDA |
| mdprc 096 05 13 000 | Technidata SAS | Laboratory Information System, TD-Synergy | FDA |
| mdprc 095 05 13 000 | Stryker Howmedica Osteonics Corp | Triathlon Femoral Distal Augment- Left | FDA |
| mdprc 094 05 13 000 | Molift AB | Lift and transport a patient, Molift Smart 150 | FDA |
| mdprc 093 05 13 000 | Depuy Orthopaedics | Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner | FDA |
| mdprc 092 05 13 000 | Chicago X-Ray Systems, Inc | x-ray system, Fona Srl IntraOs 70 intra-oral x-ray system | FDA |
| mdprc 091 05 13 000 | CEFLA DENTAL GROUP | MyRay RXDC dental unit x-ray unit | FDA |
| mdprc 081 05 13 000 | Philips Medical Systems | Computed Tomography X-ray systems, Brilliance CT 16-Slice Water | FDA |
| mdprc 080 05 13 000 | Varian Medical Systems | Pulsed Dose Rate, Segmented Cylinder Applicator Set | FDA |
| mdprc 079 05 13 000 | MEDTOX Scientific Inc | IVD Test Reagent/Kits, Immunoassay, PROFILE-V MEDTOXScan Test Devices | FDA |
| mdprc 078 05 13 000 | IRIS Diagnostics | IVD, Iris Diagnostics Division iQ Control/Focus | FDA |
| mdprc 063 05 13 000 | QIAGEN Ltd | Reagent, Qiagen artus CMV RG PCR ASR | FDA |
| mdprc 062 05 13 000 | GE Healthcare | Radiographic/Fluoroscopic Systems, General-Purpose, GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innov | FDA |
| mdprc 061 05 13 000 | Edwards Lifesciences | Procedure Kit/Trays, Cardioplegia Solution Administration, Proplege Coronary Sinus Catheter | FDA |
| mdprc 060 05 13 000 | ConMed Corporation | Electrodes, Defibrillation/Pacing, PadPro(R) Adult Radiotransparent Multifunction Electrodes | FDA |
| mdprc 050 05 13 000 | Integra LifeSciences Corporation | Biological, Collagen, Absorbable, Many products manufactured by Integra LifeSciences Corporation | FDA |
| mdprc 049 05 13 000 | Karl Storz Endoscopy America Inc | Resectoscope accessories, Karl Storz Electrode, Cutting Loops and Cold Knives | FDA |
| mdprc 048 05 13 000 | bioMerieux Inc | IVD, PREVI Isola System | FDA |
| mdprc 044 05 13 000 | Insight Instruments Inc | Multi-Port Illumination System, Insight Instruments MIS | FDA |
| mdprc 042 05 13 000 | Olympus | Electrosurgical Units, Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") | FDA |
| mdprc 041 05 13 000 | Karl Storz Endoscopy America Inc | Telescope, Camera Head, Camera System, Karl Storz Photodynamic Diagnosis (PDD) D-Light C System | FDA |
| mdprc 030 05 13 000 | Baxter Healthcare | Procedure Kit/Trays, Catheterization, Peritoneal, Dialysis, Non-DEHP Catheter Extension Set | FDA |
| mdprc 029 05 13 000 | BD Biosciences | Reagents, Molecular Assay, BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack | FDA |
| mdprc 028 05 13 000 | Cardinal Health | Procedure Kit, Various Presource Kits | FDA |
| mdprc 027 05 13 000 | Synthes Inc | Prostheses, Joint, Elbow, Synthes Radial Head Prosthesis: Trial Radial Head | FDA |
| mdprc 018 05 13 000 | Stryker Endoscopy | Suction Tips, Stryker Irrigator Reusable Tips | FDA |
| mdprc 017 05 13 000 | Owens & Minor | Absorbent tipped applicator, sterile, Antiseptic swab, Cotton bud, MediChoice® Rayon Tipped OB/GYN Applicator | FDA |
| mdprc 016 05 13 000 | NxStage Medical, Inc. | Dialysate, Hemodialysis, NxStage PureFlow-B Solution | FDA |
| mdprc 002 05 13 000 | Roche Diagnostics Corp | cobas® 8000 modular analyzer series ,Rapid PCR analyzer ,AMPLILINK ,The MagNA Pure 96 System ,DataCare POC | FDA |
| mdprc 125 04 12 001 | Integra LifeSciences Corporation | Prosthesis Implantation, Screws, Panta Arthrodesis Nail | FDA |
| mdprc 150 04 13 000 | GE Healthcare | X-ray transmission, Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117278 |
| mdprc 135 04 13 000 | Carestream Health Inc Div Onex Corp | KODAK INSIGHT DENTAL FILM in SureSoft Packets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115408 |
| mdprc 127 02 13 001 | Greiner Bio-One Inc | Blood Collection Needle Sets, 23 x 12-Inch Safety Blood Collection Sets with Luer Adapter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115829 |
| mdprc 124 04 13 000 | Spinal Solutions LLC | APLIF Implants and Instruments, The Eminent Spine Interbody Fusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116518 |
| mdprc 123 04 13 000 | Newport Medical Instruments Inc | Ventilators, HT70 and HT70 Plus ventilators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117179 |
| mdprc 104 04 13 000 | Transonic Systems Inc | AV Loop Kit For use with Transonic CO status System Only. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117016 |
| mdprc 103 04 13 000 | Heritage Labs International | IVD, Study Extra Supplies Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117176 |
| mdprc 102 04 13 000 | Advanced Sterilization Products | EVOTECH Endoscope Cleaner and Reprocessor System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117051 |
| mdprc 086 04 13 000 | Acist Medical Systems | Injectors, Contrast Media, Angiography, Model BT2000 Automated Manifold Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117164 |
| mdprc 085 04 13 000 | Nipro Corp | Blood Glucose System, Duane Reade TRUEtrack monitor kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116357 |
| mdprc 084 04 13 000 | GE Healthcare | Cardiovascular and Interventional Imaging System, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117259 |
| mdprc 083 04 13 000 | Accuray Inc | RoboCouch Patient Positioning System , support and positioning of a patient during radiosurgery. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117112 |
| mdprc 082 04 13 000 | Terumo Cardiovascular Systems Corporation | Hematocrit/Oxygen Saturation Monitoring System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106244 |
| mdprc 068 04 13 000 | Instrumentation Industries Inc | Ventilators , Manual Jet Ventilators | FDA |
| mdprc 067 04 13 000 | Roche Diagnostics Corp | IVD , Accu-CheK Inform II Blood Glucose Monitor and barcaode scanner | FDA |
| mdprc 066 04 13 000 | Siemens Healthcare Diagnostics | IVDs, clinical chemistry instrumentation, ADVIA Centaur Vitamin D Assay | FDA |
| mdprc 065 04 13 000 | Synvasive Technology Inc | Cutting ,surgical tool , Synvasive | FDA |
| mdprc 064 04 13 000 | GE Healthcare | Muse v7 cardiology information system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116925 |
| mdprc 063 04 13 000 | Synvasive Technology Inc | Surgical Saw Blade | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116702 |
| mdprc 062 04 13 000 | Smith & Nephew inc | TRIGEN (TM) L-P SCREW, orthopedic surgery | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116740 |
| mdprc 061 04 13 000 | Philips Healthcare | Computed Tomography X-Ray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116837 |
| mdprc 060 04 13 000 | Endogastric Solutions Inc | EsophyX2 Plus Device , Endoscope Clip applier | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116023 |
| mdprc 059 04 13 000 | DeGotzen | Dental X-ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116879 |
| mdprc 058 04 13 000 | Bacterin International, Inc | OsteoSelect DBM Putty , Orthopedic bone filler | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116258 |
| mdprc 049 04 13 001 | Ortho-Clinical Diagnostics | Clinical chemistry instrumentation. VITROS 4600 Chemistry System | FDA |
| mdprc 053 04 13 000 | Toshiba Corp Medical Systems Co Ltd | X-Ray, Tomography, Computed, ToshibaTSX-30IC AQUILION ONE System | FDA |
| mdprc 052 04 13 000 | US Endoscopy | Irrigation tube , Torrent irrigation system | FDA |
| mdprc 051 04 13 000 | Integra LifeSciences Corporation | Radiosurgery and Radiotherapy Treatment Planning , Integra XKnife® Stereotactic | FDA |
| mdprc 050 04 13 000 | Edwards Lifesciences | Cannula , Vascular, Perfusion , Fem-Flex II Femoral Arterial Cannula | FDA |
| mdprc 048 04 13 000 | Synthes Inc | Nails, Bone, Synthes Flexible Grip | FDA |
| mdprc 047 04 13 000 | LeMaitre Vascular GmbH | Markers, Implantable Radiographic, VascuTape Radiopaque Tape, LeMaitre Stent Guide | FDA |
| mdprc 046 04 13 000 | Cooper Surgical, Inc. | Procedure Trays, Surgical, LEEP | FDA |
| mdprc 045 04 13 000 | Medtronic Neuromodulation | Radiofrequency Therapy Systems, Tissue Ablation, Prostatic, Prostiva | FDA |
| mdprc 020 04 13 000 | Philips Medical Systems | X-RAY, TF PET/CT , imaging system | FDA |
| mdprc 019 04 13 000 | Beckman Coulter Inc | IVD, Access Immunoassay System | FDA |
| mdprc 018 04 13 000 | Zimmer inc | Retractor access system, NexPosure Portal System, placement of posterior spinal fixation implants. | FDA |
| mdprc 017 04 13 000 | Integra LifeSciences Corporation | Intraoperative cortical stimulation , Ojemann Cortical Stimulator | FDA |
| mdprc 091 03 13 001 | Smith & Nephew inc | INTERNAL HEX RECON SCREW, Orthopedic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115887 |
| mdprc 012 04 13 000 | Synthes USA (HQ) Inc. | Dens Instrument Set (Dens Graphic Case), Anterior Column Retractor Set,fractures bone | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115737 |
| mdprc 011 04 13 000 | Microbiologics Inc | IVD, KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116205 |
| mdprc 010 04 13 000 | COOPER SURGICAL INC. | Omniflex Diaphragm , contraceptive device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116371 |
| mdprc 009 04 13 000 | Zyno Medical LLC | Z-800 Volumetric Infusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116161 |
| mdprc 008 04 13 000 | Smiths Medical ASD Inc | 9004 Capnocheck® Capnography , PULSE OXIMETERS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116450 |
| mdprc 004 04 13 000 | Gen-Probe Incorporated | IVD Test Reagent/Kits, Immunoassay, Immunology, LIFECODES PF4 Enhanced Assay Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116359 |
| mdprc 003 04 13 000 | CareFusion Corp | Pyxis Anesthesia System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86996 |
| mdprc 002 04 13 000 | Cardinal Health | Needle, Sterile Needle Counters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115143 |
| mdprc 147 03 13 000 | Smiths Medical | Medfusion Model 3500 Syringe Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114372 |
| mdprc 146 03 13 000 | Kimberly Clark Health Care | Sterilization Packaging, KIMGUARD Container Filters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116773 |
| mdprc 136 03 13 000 | Toshiba Corp Medical Systems Co Ltd | Toshiba Infinix-i X-Ray System, A radiographic and fluoroscopic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116745 |
| mdprc 133 03 13 000 | Intio Inc | ClearStart-SVM" , semi-automated tools for segmentation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116141 |
| mdprc 132 03 13 000 | Spacelabs Healthcare Inc | BleaseFocus Anesthesia Workstation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116425 |
| mdprc 131 03 13 000 | Mindray DS USA, Inc. | IVD, BS-200 Chemistry Analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115382 |
| mdprc 130 03 13 000 | Keystone Dental Inc | Implant, PrimaConnex Tapered Implant TC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116685 |
| mdprc 124 03 13 000 | AGFA Corp. | CR 10-X, x-ray imager image plate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116405 |
| mdprc 112 03 13 000 | Stryker Howmedica Osteonics Corp | Orthopaedics , Triathlon Left and Right | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116175 |
| mdprc 111 03 13 000 | Molded Products Inc | Sterile Access & Return Line Set, hemodialysis blood tubing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116207 |
| mdprc 110 03 13 000 | Alphatec Spine Inc | Osteosynthesis, bone screws, IILICO MIS Posterior Spinal Fixation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90188 |
| mdprc 109 03 13 000 | Allen Medical Systems | Ankle Traction Boot, Orthopedic Leg Holders | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116368 |
| mdprc 097 03 13 000 | Synthes USA (HQ) Inc. | Variable Angle Locking Compression Plate, Variable Angle LCP Dorsal Distal Radius System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115544 |
| mdprc 096 03 13 000 | Hill Rom Inc | TotalCare SpO2RT2 bed, flotation therapy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116540 |
| mdprc 095 03 13 000 | Exactech | The Optetrak Logic Comprehensive Knee Systems, Proximal Tibial Spacer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116190 |
| mdprc 094 03 13 000 | Ebi, Llc | Screw fixation system, Biomet Spine Polaris 5.5 Button Lock Screw Inserter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116169 |
| mdprc 093 03 13 000 | Beckman Coulter Inc | IVD, Creatinine,System reagent , AU analyzers. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115469 |
| mdprc 090 03 13 000 | Natus Medical Inc | Nicolet EEG Wireless Amplifier ,electrophysiological signals | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116224 |
| mdprc 089 03 13 000 | Philips Medical Systems | Computed Tomography, X-Ray Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116035 |
| mdprc 087 03 13 000 | Bacterin International, Inc | Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless,surgical wound drainage. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115836 |
| mdprc 025 02 13 001 | Ormco Corp | Lightspeed LSX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115470 |
| mdprc 067 03 13 000 | Synthes Inc | X Pedicle Screw , stabilization of the spine | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115816 |
| mdprc 066 03 13 000 | Synthes Inc | Large Combination Clamp/Large External Fixation System, bone and pelvic fractures | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115818 |
| mdprc 065 03 13 000 | GE Healthcare | Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Cardiovascular X-ray imaging systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115743 |
| mdprc 062 03 13 000 | Keystone Dental Inc | Straight Esthetic 5.0 mm 3. mm ,Cuff Abutment ,surgical, bone | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116219 |
| mdprc 061 03 13 000 | Innominata Dba Genbio | IVD, MICROPLATE EIA Kit,ANTI-BORRELIA (LYME) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115898 |
| mdprc 060 03 13 000 | Elekta Inc | Synergy XVI, Digital Imager, Radiation Therapy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115474 |
| mdprc 059 03 13 000 | Stryker Osteosynthesis Intramedullary Solutions | Measure the height of the disc space intra-operatively, Stryker AVS Navigator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108786 |
| mdprc 058 03 13 000 | Medtronic Navigation Inc | O-arm Imaging System ,fluoroscopic x-ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115675 |
| mdprc 057 03 13 000 | Genesys Orthopedic Systems | Cervical Screws, 3.75mm x 12mm , Spine Anterior Cervical | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116108 |
| mdprc 056 03 13 000 | Biomet Inc | Straight Acetabular Inserter Handle , surgical,bone | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115921 |
| mdprc 053 03 13 000 | Churchill Medical A Vygon Co | Lifeguard Infusion Set with Smartsite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116188 |
| mdprc 052 03 13 000 | Bard Access Systems | Catheters, Vascular, Infusion, Central Venous, Hickman and Leonard Dual-Lumen Catheter Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116113 |
| mdprc 051 03 13 000 | AtriCure Inc | The Isolator Transpolar Pen ,ablate cardiac tissues | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116050 |
| mdprc 082 02 12 001 | Siemens Medical Solutions | Therapeutic treatment of cancer, ARTISTE and ONCOR linear accelerator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105696 |
| mdprc 031 03 13 000 | Synthes Inc | Distractors, Various Multiaxial Manual Multi-Vector Distractors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116033 |
| mdprc 025 03 13 000 | Salyer Prn Biomedical | Century Console Base,use as a platform ,for other ancillary equipment and disposable products in cardiopulmonary surgical procedures | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115964 |
| mdprc 024 03 13 000 | Philips Healthcare | IMAGING ,Stationary radiographic system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114455 |
| mdprc 023 03 13 000 | GE Healthcare | Volume Viewer Plus, Volume Analysis, Advantage Workstation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115318 |
| mdprc 022 03 13 000 | Philips Medical Systems | CT Scanner System ,The MX 16-Slice , X-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115986 |
| mdprc 021 03 13 000 | Myco Medical Supplies | cutting device,Technocut Plus,Scalpel,surgical | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116137 |
| mdprc 020 03 13 000 | GE Healthcare | X-Ray System , Definium 5000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115405 |
| mdprc 006 03 13 000 | Oculus Innovative Sciences Inc | Gel burn,Atrapro Antipruritic Hydrogel, 1.5 oz gel tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115812 |
| mdprc 005 03 13 000 | Aesculap | Bipolar Coagulator ,use in surgery | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116053 |
| mdprc 199 02 13 000 | Integra LifeSciences Corporation | Electrosurgical Units, Monopolar, Jarit Monopolar Cables Used with Jarit Endoscopic Instruments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115922 |
| mdprc 198 02 13 000 | GE Healthcare | X-Ray System / Brivo XR385 DR-F | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115627 |
| mdprc 174 02 13 000 | Mc-NEIL-PPC, Inc | KY® TINGLING® JELLY Personal Lubricant,Vaginal Moisturizer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110244 |
| mdprc 173 02 13 000 | Intel-GE Care Innovations LLC | The QuietCare system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115109 |
| mdprc 172 02 13 000 | Integra LifeSciences Corporation | Base Unit Standard | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115508 |
| mdprc 171 02 13 000 | Hill Rom Inc | Overhead Rail System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110244 |
| mdprc 170 02 13 000 | Bayer Healthcare LLC | Angiography Kits, Medrad Hand Controller Sheaths | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115839 |
| mdprc 169 02 13 000 | Stryker Sustainability Solutions | Restep DVT System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114588 |
| mdprc 168 02 13 000 | Merit Medical Systems Inc | The Resolve Biliary Locking Drainage Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115545 |
| mdprc 167 02 13 000 | Ansell Healthcare Products LLC | LifeStyles ZERO 10 uber-thin lubricated latex condoms | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115660 |
| mdprc 134 02 13 000 | HealthTronics Inc | Endocare 3.8mm RenalCryo Cryoprobe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115069 |
| mdprc 128 02 13 000 | Lockheed Martin | camera systems ,Laser pointer and illuminator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115239 |
| mdprc 126 02 13 000 | GE Healthcare | Monitor,CARESCAPE Monitor B650 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115653 |
| mdprc 125 02 13 000 | GE Healthcare | Dash Port 2 Docking Station,monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114428 |
| mdprc 123 02 13 000 | Depuy Orthopaedics, Inc | LPS Diaphyseal Sleeves | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114764 |
| mdprc 117 02 13 000 | Fresenius Medical Care | Peritoneal Dialysis Sterile Connection Units, LIBERTY Automated Peritoneal Dialysis System Line Cycler Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115494 |
| mdprc 114 02 13 000 | GE Healthcare | The Dash 3000/4000/5000 ,patient monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114419 |
| mdprc 113 02 13 000 | Mizuho OSI | Orthopedic Systems, The table | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115181 |
| mdprc 112 02 13 000 | Breg Inc, An Orthofix Company | Pads, Circulating-Fluid, Sterile Polar Pads Contained in Cold Therapy Combination Units | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115498 |
| mdprc 111 02 13 000 | Aesculap | Miethke Shunt System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113098 |
| mdprc 089 02 13 000 | Exactech | Prostheses, Joint, Hip, Novation Crown Cup Connection GXL Neutral Liners | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115319 |
| mdprc 088 02 13 001 | Custom Healthcare System | Sterile medical device containing multiple components to perform a breast biopsy , Breast Biopsy Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115337 |
| mdprc 087 02 13 000 | Bacterin International, Inc | Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects , | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113766 |
| mdprc 054 09 12 001 | Linvatec Corp. | Bone Punch, PopLok Punch | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111312 |
| mdprc 071 02 13 000 | Westone Laboratories, Inc | Patient lubricant, OTO EASE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110825 |
| mdprc 058 02 13 000 | Winco, Inc. | Chair, Recliner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114733 |
| mdprc 057 02 13 000 | The Anspach Effort, Inc. | Bearing Sleeve with Removable Bur Guard | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114783 |
| mdprc 056 02 13 000 | Lansinoh Laboratories | THERA PEARL 3-in-1 BREAST THERAPY | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115101 |
| mdprc 055 02 13 000 | Invacare Corporation | Solara 3G Custom Manual Wheelchair | Z-0785-2013 |
| mdprc 028 02 13 000 | Tobii Technology AB | P10 Tobii battery pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115353 |
| mdprc 011 02 13 000 | Motorola Inc | PCS3000/CS3070 Laser | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109265 |
| mdprc 010 02 13 000 | Moog Inc | Infinity Enteral Feeding infusion pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113975 |
| mdprc 009 02 13 000 | Hamilton Medical Inc | HAMILTON-T1 Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115383 |
| mdprc 008 02 13 000 | GE Healthcare | AdvantageSim MD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108534 |
| mdprc 007 02 13 000 | Extremity Medical | Prosthesis Implantation Instruments, Orthopedic, IO FiX Screw Measuring Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114794 |
| mdprc 005 02 13 000 | Biomet Inc | Screws, Bone, TunneLoc Round Head Interference Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115199 |
| mdprc 130 01 13 000 | Philips Medical Systems | Juno DRF , X-ray system, diagnostic, Fluoroscopic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114934 |
| mdprc 129 01 13 000 | Alfa Wassermann, Inc. | Alfa Wassermann System Diluent 750 mL ,water solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114930 |
| mdprc 115 01 13 000 | Mindray DS USA, Inc. | DPM5 Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114790 |
| mdprc 109 01 13 000 | Medisystems Corp | Buttonhole Needle Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115204 |
| mdprc 108 01 13 000 | Cordis Corporation | Clips, Surgical, Wound Closure, ExoSeal Vascular Closure Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114845 |
| mdprc 107 01 13 000 | BioMerieux Inc | BacT/ALERT SA Blood Culture Bottle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115293 |
| mdprc 106 01 13 000 | DePuy Spine, Inc. | Spine VIPER POLY SCREW 5.5 8 X80MM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114495 |
| mdprc 105 01 13 000 | Becton Dickinson & Co. (BD) | Analyzers, Laboratory, Molecular Assay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115099 |
| mdprc 078 01 13 000 | Vycor Medical | Viewsite Brain Access System (VBAS) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113513 |
| mdprc 077 01 13 000 | Immunodiagnostic Systems Limited | The IDS 25-Hydroxy Vitamin D EIA kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114873 |
| mdprc 076 01 13 000 | Becton Dickinson & Co. (BD) | BBL Crystal Enteric/Nonfermenter ID Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115111 |
| mdprc 072 01 13 000 | Sunquest Information Systems Inc | Sunquest Laboratory | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113605 |
| mdprc 071 01 13 000 | Sunquest Information Systems Inc | Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113627 |
| mdprc 070 01 13 000 | Radiometer Medical | automated analyzer, ABL80 FLEX CO-OX analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113592 |
| mdprc 069 01 13 000 | OrthoPediatrics Corp | Nails, Bone, Trochar Scalpel Instruments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113679 |
| mdprc 068 01 13 000 | Spacelabs Healthcare Inc | Patient health record,information system, Intesys Clinical Suite (ICS) G2 Smart Disclosure | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115067 |
| mdprc 067 01 13 000 | Quanta System | Eterna Giovinezza System,Ultrawave II EX 1320/ Ultrawave III EX 1320 ,Q-Plus T,Powered Laser Surgical Instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115258 |
| mdprc 066 01 13 000 | Philips Medical Systems | Computed Tomography X-Ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114728 |
| mdprc 055 01 13 000 | Philips Medical Systems | CT Computed Tomography ,Brilliance 64 and Ingenuity | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114827 |
| mdprc 083 08 12 001 | GE Medical Systems | Image-intensified fluoroscopic x-ray system, OEC 8800 Flexview and OEC 6800 Miniview | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110394 |
| mdprc 045 01 13 000 | Terumo Cardiovascular Systems Corporation | Aortic Arch Cannula and Sarns | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115298 |
| mdprc 044 01 13 000 | Siemens Healthcare Diagnostics | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114962 |
| mdprc 042 01 13 000 | Merit Medical Systems Inc | Procedural Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113073 |
| mdprc 027 01 13 000 | MAQUET Cardiovascular LLC | CARDIOSAVE Intra-Aortic Balloon Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109877 |
| mdprc 026 01 13 000 | Concentric Medical Inc | FlowGate Balloon Guide Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115074 |
| mdprc 024 01 13 000 | Surgical Tissue Network Inc | UltraFill DBM,Donated Human Tissue Allograft | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113638 |
| mdprc 023 01 13 000 | California Medical Laboratories Inc | Suction Kits, Standard Rigid Tip Suction Wands | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114967 |
| mdprc 022 01 13 000 | Applied Medical Resources | Kii Shielded Bladed Access System,Laparoscope | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114879 |
| mdprc 021 01 13 000 | Philips Medical Systems | Defibrillator,HeartStart FRx 861304 , Laerdal brands of HeartStart HS1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112328 |
| mdprc 020 01 13 000 | Stryker Medical | Medical Surgical Bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114351 |
| mdprc 019 01 13 000 | Mindray DS USA, Inc | DPM Central Station | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114367 |
| mdprc 018 01 13 000 | HORIBA ABX Diagnostics | The Pentra C200 system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114865 |
| mdprc 017 01 13 000 | Fisher & Paykel Healthcare Inc | 900MR068Reusable breathing circuit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114789 |
| mdprc 013 01 13 000 | B Braun Medical Inc | Space Pump Pole Clamps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114927 |
| mdprc 011 01 13 000 | Terumo Cardiovascular Systems Corporation | Terumo Backplate Replacement CXFVR 1500 Holder | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113066 |
| mdprc 010 01 13 000 | GE Healthcare | Mobile X-ray system, innova | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112315 |
| mdprc 007 01 13 000 | Medtronic Inc | Heart-Lung Bypass Unit Tubing Sets, Intersept Tubing Packs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114738 |
| mdprc 006 01 13 000 | GE Healthcare | Giraffe and Panda Warmer T-Piece Resuscitation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112681 |
| mdprc 005 01 13 000 | Brookstone Company | Brookstone Heated Body Bean | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114063 |
| mdprc 003 01 13 000 | Arjo Inc | Flowtron Trio DVT Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114918 |
| mdprc 002 01 13 000 | Osteotech Inc | Grafts, Bone, Various Grafton Bone Graft Materials | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112940 |
| mdprc 001 01 13 000 | MOOG Medical Devices Group | Infusion Pumps, Ambulatory, Moog Ambulatory Administration Sets Used with Moog Curlin Ambulatory Pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113568 |
| mdprc 162 12 12 000 | Teleflex Medical | Ligating Clips, Hem-o-lok Large Polymer Ligating Clips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113590 |
| mdprc 161 12 12 000 | GE Healthcare | Mammography systems, Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108524 |
| mdprc 160 12 12 000 | Aesculap | Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113061 |
| mdprc 159 12 12 000 | Sanofi-Aventis | Diamigo i-Phone App | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114792 |
| mdprc 158 12 12 000 | Varian Medical Systems | Brachytherapy Applicator, Segmented Cervix Applicator Set, Guide tube for segments and cervical sleeves | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114525 |
| mdprc 157 12 12 000 | Praxair Inc | OX-M-AEGNGVNTG,Praxair Vantage ,Cylinder pressure regulator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114654 |
| mdprc 156 12 12 000 | Philips Medical Systems | Computed Tomography X-Ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114188 |
| mdprc 155 12 12 000 | Depuy Orthopaedics, Inc | SOLUTION System Calcar Stems ,SOL SYS L 9IN CALC 2.25/15.0 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114637 |
| mdprc 154 12 12 000 | BioMotion Medical Systems, LLC | BioMotion Spinal System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114771 |
| mdprc 153 12 12 000 | Spacelabs Healthcare Inc | BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114600 |
| mdprc 152 12 12 000 | GE Healthcare | Advantage Workstation Volume Share 2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108512 |
| mdprc 151 12 12 000 | Integra LifeSciences Corporation | MAYFIELD Composite Series Skull Clamps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114755 |
| mdprc 150 12 12 000 | Becton Dickinson & Co. (BD) | BD Phoenix PMIC-108 Panels | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114682 |
| mdprc 144 12 12 000 | Stryker Medical | Stretchers, Mobile, Ambulance, Model 6390 Power-LOAD Ambulance Cot Fastener Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114920 |
| mdprc 143 12 12 000 | Medline Industries Inc | Medline Angio Drape Pack Radiology-LF | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114684 |
| mdprc 142 12 12 000 | Depuy Orthopaedics, Inc | Pinnacle Cancellous Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111672 |
| mdprc 141 12 12 000 | Zimmer inc | Coonrad/Morrey New Ulnar Revision Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114543 |
| mdprc 140 12 12 000 | Zimmer inc | The Personalized Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114661 |
| mdprc 139 12 12 000 | Invacare Corporation. | Canes, Adjustable-Length, Offset-Handle, Offset and Standard Crook Canes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114753 |
| mdprc 138 12 12 000 | Varian Medical Systems | ARIA Oncology Information System Radiation Oncology | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114598 |
| mdprc 135 12 12 000 | TITAN SPINE | Spine Endoskeleton TA Implant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114191 |
| mdprc 132 12 12 000 | Mindray DS USA, Inc., dba Datascope Patient Monitoring | The V Series Monitor , Patient Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114418 |
| mdprc 130 12 12 000 | Medline Industries Inc | Knee CDS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114135 |
| mdprc 128 12 12 000 | EEG Info | EEG NeuroAmp | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114838 |
| mdprc 125 12 12 000 | Depuy Mitek | Sterile Reamers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114672 |
| mdprc 123 12 12 000 | Arobella Medical LLC | AR1000 Qoustic Qurette,Wound Therapy System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114801 |
| mdprc 115 12 12 000 | Sysmex America Inc | IVD, Sysmex XE-2100C, Sysmex XE-2100 and Sysmex XE-5000 automated hematology analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113587 |
| mdprc 114 12 12 000 | Sechrist Industries Inc | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84025 |
| mdprc 113 12 12 000 | GE Healthcare | Carescape Patient Data Module v2.0, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114421 |
| mdprc 112 12 12 000 | GE Healthcare | The Dash 3000/4000/5000 ,patient monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114415 |
| mdprc 111 12 12 000 | Bunnell Inc | Breathing Circuits, Ventilator, Disposable Patient Circuits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114595 |
| mdprc 110 12 12 000 | Becton Dickinson & Co. (BD) | BD BBL Taxo XV Factor Strips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114627 |
| mdprc 109 12 12 000 | Zimmer inc | Prostheses, Joint, Hip, Femoral Component, CPT Modular Stems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112643 |
| mdprc 108 12 12 000 | Linvatec Corp. | Orthopedic surgical procedures, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112590 |
| mdprc 107 12 12 000 | Beckman Coulter Inc | IVD, UniCel Closed Tube Aliquotter for UniCel DxC 660i, 680i, 860i and 880i Synchron Access Clinical Sys | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112909 |
| mdprc 106 12 12 000 | Quasar Bio-Tech | An infrared LED lamp | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114151 |
| mdprc 086 12 12 001 | Siemens Healthcare Diagnostics | IVD Test Reagent/Kits, Emit(R) 2000 Phenobarbital Assay and Syva(R) Emit(R) Phenobarbital Assay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111800 |
| mdprc 089 12 12 000 | Ventlab Corp | Resuscitators, Various Manual Resuscitators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114235 |
| mdprc 088 12 12 000 | Siemens Healthcare Diagnostics | IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Iron, Dimension Vista System IRON Flex Reagent Cartridges | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113760 |
| mdprc 087 12 12 000 | Winco, Inc. | Chairs, Examination/Treatment, Caremor Cliner Recliner Chairs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112495 |
| mdprc 085 12 12 000 | Remington Medical | Needles, Biopsy, Soft Tissue Biopsy Needles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112454 |
| mdprc 084 12 12 000 | OrthoHelix Surgical Design Inc | Screw, Mini MaxTorque Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89070 |
| mdprc 083 12 12 000 | Kardium Inc | TORQ Sternal Closure Device, TWISTER, WIRE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112575 |
| mdprc 082 12 12 000 | Immunodiagnostic Systems Limited | IVD, IDS-Isys Multi-Discipline Automated Analyser | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112212 |
| mdprc 081 12 12 000 | Alere San Diego | Fluorescence immunoassay, Triage TOX Drug Screen Panel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112805 |
| mdprc 080 12 12 000 | 3M Health Care Ltd | Sterilizing Units, Germicidal Gas, Ethylene Oxide, Steri-Vac Sterilizer/Aerators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113036 |
| mdprc 079 12 12 000 | Philips Healthcare | The Information Center Software ,Philips IntelliVue | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114593 |
| mdprc 078 12 12 000 | Parks Medical | Cardiovascular blood flowmeter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113079 |
| mdprc 077 12 12 000 | Covidien | Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107563 |
| mdprc 076 12 12 000 | ConMed Corporation | WANG Transbronchial Aspiration Needles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114678 |
| mdprc 075 12 12 000 | Terumo Cardiovascular Systems Corporation | Centrifugal System, cardiopulmonary bypass, Sarns" | FDA |
| mdprc 074 12 12 000 | Siemens Medical Solutions | Radiological image processing system, syngo.plaza | FDA |
| mdprc 073 12 12 000 | ICU Medical, Inc | Waste system, 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod | FDA |
| mdprc 057 12 12 000 | Synthes USA (HQ) Inc. | Treatment of proximal humerus fractures, 4.5mm TI Multiloc Screw Length | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110178 |
| mdprc 056 12 12 000 | Philips Healthcare | Digital Diagnost ,X-ray systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114371 |
| mdprc 055 12 12 000 | Neusoft Medical Systems | CT Scanner System and NeuViz Dual series CT Scanner System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114197 |
| mdprc 054 12 12 000 | iwalk inc | Li-Ion Rechargeable Batteries and Battery Chargers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=11441 |
| mdprc 053 12 12 000 | Biomet Inc | OSS Reamer Sleeve | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114363 |
| mdprc 048 12 12 000 | Terumo Cardiovascular Systems Corporation | Soft Flow Aortic Cannulae | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113708 |
| mdprc 047 12 12 000 | Stryker Instruments | Neptune 2 Rover -Ultra , Max Vacuum | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114391 |
| mdprc 046 12 12 000 | Siemens Medical Solutions | Syngo.plaza ,Radiological Image Processing System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114137 |
| mdprc 045 12 12 000 | Sekisui Diagnostics | Sekisui Diagnostics, Spectrolyse | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114366 |
| mdprc 044 12 12 000 | OmniGuide Inc | BP-ROBOTIC The OmniGuide Fiber | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114404 |
| mdprc 043 12 12 000 | Merit Medical Systems Inc | Custom Procedural Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111628 |
| mdprc 041 12 12 000 | Natus Medical Inc | Olympic Cool-Cap system, a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109204 |
| mdprc 040 12 12 000 | Medtronic Navigation Inc | Drill Guide,used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114623 |
| mdprc 039 12 12 000 | Kimberly Clark Health Care | Patient Warming System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114416 |
| mdprc 037 12 12 000 | IRadimed Corp | Infusion Pump, Mridium Series 1000, Infusion Sets. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114544 |
| mdprc 036 12 12 000 | GE Healthcare | Mobile X-ray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113027 |
| mdprc 004 12 12 000 | Zimmer inc | Knee prostheses, NexGen CompleteKnee Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114183 |
| mdprc 003 12 12 000 | Terumo Cardiovascular Systems Corporation | Advanced Perfusion System Platform (APS) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114179 |
| mdprc 002 12 12 000 | Cooper Surgical Inc | Cannulae, Intrauterine, Arch Style Uterine Manipulation System Handles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114523 |
| mdprc 001 12 12 000 | Biomet Inc | Orthopedic Implant, Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114596 |
| mdprc 139 11 12 000 | Zimmer inc | Prostheses, Trilogy Acetabular System Shell Prostheses with Cluster Holes. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114176 |
| mdprc 138 11 12 000 | SpineFrontier Inc | Fixation system, Spine Frontier Inspan compressors. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112677 |
| mdprc 137 11 12 000 | SpineFrontier Inc | Surgical Guides, S-Lift Implant Guides. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112475 |
| mdprc 136 11 12 000 | OrthoPediatrics Corp | Extension osteotomy bone plate system, PLEO Osteotomy Guide | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114199 |
| mdprc 135 11 12 000 | King Systems Corp. | Laryngeal Airway Devices, KING LAD Silicone Flexible ClearSeal Single use. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114250 |
| mdprc 134 11 12 000 | Captiva Spine, Inc | Spinal fixation, CapLOX II Pedicle Screw spinal System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114524 |
| mdprc 133 11 12 000 | Biomet Inc | hip replacement, Ranawat/Burnstein Acetabular Shell | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114365 |
| mdprc 132 11 12 000 | bioMerieux Inc | Analyzers, Sodium Chloride (NaCl) Injection. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114061 |
| mdprc 107 11 12 000 | Zimmer inc | Prostheses, Joint, Hip, Femoral Component, Multipolar Bipolar Cup Liners | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112642 |
| mdprc 106 11 12 000 | Zimmer inc | Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112648 |
| mdprc 105 11 12 000 | Siemens Healthcare Diagnostics | Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111837 |
| mdprc 104 11 12 000 | KCI USA Inc | RotoRest Delta Kinetic Therapy System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111749 |
| mdprc 103 11 12 000 | Gyrus ACMI | Tympanostomy tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114384 |
| mdprc 102 11 12 000 | Carl Zeiss Meditec Inc | INTRABEAM Balloon Applicator Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114297 |
| mdprc 101 11 12 000 | NuVasive Inc | SpheRx® Posted Pedicle Screw System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=83509 |
| mdprc 100 11 12 000 | MAKO Surgical Corp | The RIO ,surgical knee, orthopedic and hip procedure. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114357 |
| mdprc 099 11 12 000 | Linvatec Corp. | Drills, Surgical Bit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112472 |
| mdprc 098 11 12 000 | Beckman Coulter | In vitro diagnostic , UniCel Dxl Access Immunoassay System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114074 |
| mdprc 090 11 12 000 | Sorin Group | Pump Control Panel, Stockert Centrifugal Pump, S5 and S3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113636 |
| mdprc 089 11 12 000 | Oscor | Guide Wires, Myocardial Heart Wires | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112581 |
| mdprc 088 11 12 000 | Linvatec Corp. | create pathway, CrossFT Suture | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112522 |
| mdprc 087 11 12 000 | First Medical Source LLC | Infusion Pump, WOLFPAK, Medpro, Vipat | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104881 |
| mdprc 085 11 12 000 | Mindray DS USA, Inc. | Mindray A5 Anesthesia Delivery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113482 |
| mdprc 084 11 12 000 | Extremity Medical LLC | IntraOsseous Fixation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112032 |
| mdprc 083 11 12 000 | Moog Inc | Infinity Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114426 |
| mdprc 082 11 12 000 | GE Healthcare | Electrodes, Electrocardiographic, Neonatal, Corometrics Quik Connect Plus Spiral Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113969 |
| mdprc 081 11 12 000 | Zimmer inc | Tourniquets, A.T.S. 3000 Automatic Tourniquet Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113932 |
| mdprc 080 11 12 000 | GE Healthcare | Mobile X - Ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114307 |
| mdprc 079 11 12 000 | Sorin | Fittings/Adapters, Luer, Gish Connector with Luer fitting | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113571 |
| mdprc 078 11 12 000 | Progressive Medical Inc | Dissectors, Endoscopic Dissectors with Kittner Tips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110395 |
| mdprc 077 11 12 000 | Orthosensor | Graphic user interface, ORTHO SENSOR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112490 |
| mdprc 076 11 12 000 | Nipro Corp | Guide Wires, Various Aqualiner Hydrophilic Guidewires | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113448 |
| mdprc 075 11 12 000 | GE Healthcare | Workstations, Multiple Modality, Three-Dimensional Image, Seno Advantage 2.2 Workstations | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108537 |
| mdprc 074 11 12 000 | Encore Medical, Lp | Bone Screw, 6.5mm Cancellous Bone Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113489 |
| mdprc 073 11 12 000 | Elekta Inc | Radiation treatment planning software, Oncentra External Beam 4.1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113697 |
| mdprc 072 11 12 000 | DePuy International Limited | Suture Anchors, SPIRALOK Suture Anchors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112639 |
| mdprc 071 11 12 000 | Baxa Corp | Fluid Transfer Tube Sets, Repeater Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113637 |
| mdprc 070 11 12 000 | Ethicon Inc | SURGIFLO HEMOSTATIC MATRIX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113490 |
| mdprc 069 11 12 000 | bioMerieux Inc | BioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113980 |
| mdprc 068 11 12 000 | Synthes Inc | Synthes External Fixation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113797 |
| mdprc 067 11 12 000 | Terumo Cardiovascular Systems Corporation | HX2 Temperature Management System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113534 |
| mdprc 066 11 12 000 | Terumo Cardiovascular Systems Corporation | Arterial perfusion | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111544 |
| mdprc 065 11 12 000 | Trivascular Inc | TriVascular brand Fill Polymer Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=1142 |
| mdprc 064 11 12 000 | Dako North America Inc | PT Link Waterbath | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=85291 |
| mdprc 061 11 12 000 | Micro Therapeutics Inc | UltraFlow HPC Flow Directed Micro Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112884 |
| mdprc 060 11 12 000 | Zimmer inc | Drills, Bone, Cemented Tibial Drills Used with Persona Personalized Knee Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112646 |
| mdprc 059 11 12 000 | Zimmer inc | Prostheses, Joint, Hip, Femoral Component, MIS and VerSys Provisional Femoral Head Prostheses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112435 |
| mdprc 058 11 12 000 | Stanley Healthcare Solutions | Monitors, TABS Professional Monitors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109106 |
| mdprc 057 11 12 000 | Philips Healthcare | Stationary radiographic System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112761 |
| mdprc 056 11 12 000 | Invacare Corporation. | Chairs, Bath, I-Fit Shower Chairs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112225 |
| mdprc 055 11 12 000 | KCI USA Inc | Mattress Systems, Low-Air-Loss, BariAir Therapy Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112188 |
| mdprc 054 11 12 000 | EOS Imaging | EOS X-ray Medical Diagnostic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111193 |
| mdprc 053 11 12 000 | Biomet Inc | Screwdrivers, Bone, OptiLock Screwdrivers and Inserters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112460 |
| mdprc 052 11 12 000 | Imaging Sciences International Inc | DEXIS Imaging Suite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111796 |
| mdprc 051 11 12 000 | Westmed Inc | Pulset Arterial Blood Gas (ABG) sampling kit, TRIAD brand alcohol pads | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113400 |
| mdprc 050 11 12 000 | Ethicon Inc | Adhesives, EVICEL Fibrin Sealant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113110 |
| mdprc 049 11 12 000 | DePuy International Limited | Radiofrequency System, VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113405 |
| mdprc 048 11 12 000 | Greatbatch | Steerable Sheath | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112674 |
| mdprc 047 11 12 000 | Beckman Coulter Inc | IVD, clinical chemistry analyzers, UniCel® DxC 600/800 Synchron® Clinical Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112676 |
| mdprc 046 11 12 000 | AdvanDx, Inc | IVD, E. coli/P. aeruginosa PNA FISH | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112961 |
| mdprc 045 11 12 000 | AdvanDx, Inc | IVD, Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa, GNR Traffic Light PNA FISH | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113037 |
| mdprc 044 11 12 000 | Advanced Bionics Corp. | HiResolution Bionic Ear System, HiRes 90K cochlear implant with HiFocus Helix Electrode | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113560 |
| mdprc 043 11 12 000 | Progressive Medical Inc | Endoscopic Dissector with Kittner Tip (5mm c 40cm | FDA |
| mdprc 042 11 12 000 | Alphatec Spine Inc | Zodiac Pedicle Screw System | FDA |
| mdprc 037 11 12 000 | Primus Medical LLC | Prime Bed TL500 Bed Frame | FDA |
| mdprc 036 11 12 000 | Neomend Inc | Progel Pleural Air Leak Sealant | FDA |
| mdprc 035 11 12 000 | Linvatec Corp. | Light Source, Endoscopic, Xenon Arc | FDA |
| mdprc 034 11 12 000 | Hologic Inc | Hologic Fluoroscan Mini C-Arm | FDA |
| mdprc 033 11 12 000 | Alere LTD | Reagents, Immunoassay, Rapid Test, Drug-of-Abuse, Triage TOX Drug Screen 9-Panel Reagent Kits | FDA |
| mdprc 032 11 12 000 | Terumo Cardiovascular Systems Corporation | Heart-Lung Bypass Units, Terumo Advanced Perfusion System 1 Flow Modules | FDA |
| mdprc 030 11 12 000 | Terumo Cardiovascular Systems Corporation | Heart-Lung Bypass Units, Terumo Advanced Perfusion System 1 Flow Modules | FDA |
| mdprc 029 11 12 000 | Philips Medical Systems | Computed Tomography X-Ray Systems | FDA |
| mdprc 028 11 12 000 | Beckman Coulter Inc | immunoradiometric assay kit , Active Renin IRMA Kit | FDA |
| mdprc 027 11 12 000 | Accuro Medical Product LLC | Negative Pressure Wound Therapy Powered Suction Pump | FDA |
| mdprc 026 11 12 000 | US Endoscopy | Raptor Endoscopic retrieval device. | FDA |
| mdprc 025 11 12 000 | Synthes Inc | Synthes Minimally Invasive Reduction Screw System (MIRS) | FDA |
| mdprc 024 11 12 000 | Cure Medical Llc | Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16 | FDA |
| mdprc 023 11 12 000 | Beckman Coulter Inc | IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent | FDA |
| mdprc 048 10 12 000 | Cordis Corporation | Sleek OTW***REF 426-1201X***Inflated Balloon | FDA |
| mdprc 047 10 12 000 | Opti Medical Systems Inc | BP7561 OPTI CCA-TS B-Lac Cassette | FDA |
| mdprc 046 10 12 000 | Covidien | Covidien Duet TRS Loading Unit | FDA |
| mdprc 045 10 12 000 | Accutron Inc | Newport Portable Package | FDA |
| mdprc 037 10 12 000 | Siemens Medical Solutions | Mobile x-ray system, Mobilett Mira | FDA |
| mdprc 036 10 12 000 | Edwards Lifesciences | Catheters, Swan-Ganz Thermodilution VIP Catheters | FDA |
| mdprc 033 10 12 000 | Steris Corp | Surgical Tables | FDA |
| mdprc 032 10 12 000 | Smith & Nephew Orthopaedic | Prostheses, Joint, Hip, Femoral Component, 12/14 Taper High Offset Necks | FDA |
| mdprc 031 10 12 000 | Baxter Healthcare | Baxter Clearlink System Buretrol Solution Set with 150 mL Burette - Non-DEHP | FDA |
| mdprc 030 10 12 000 | Haag-Streit AG | Octopus 101 Perimeter | FDA |
| mdprc 029 10 12 000 | Custom Medical Specialties, Inc | Povidine-Iodine prep solution/Providine prep pads | FDA |
| mdprc 028 10 12 000 | Depuy Orthopaedics, Inc | S-Rom® Total Hip System Poly Liner | FDA |
| mdprc 027 10 12 000 | Steris Corporation | Verify® Bowie-Dick Test Card | FDA |
| mdprc 026 10 12 000 | Sekisui Diagnostics | Spectrolyse PAI-1 | FDA |
| mdprc 025 10 12 000 | Roche Diagnostics Corp | Amplilink Software v3.2 | FDA |
| mdprc 024 10 12 000 | Integra LifeSciences Corporation | Head Ring Assembly with Intubation Mounts (HRAIM) | FDA |
| mdprc 023 10 12 000 | Davol | Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810 | FDA |
| mdprc 022 10 12 000 | Asahi Kasei Medical Co | Hemodialyzer | FDA |
| mdprc 021 10 12 000 | Kimberly Clark Health Care | Kimberly-Clark MIC PEG Kit - Pull Type | FDA |
| mdprc 020 10 12 000 | ZOLL Medical Corp | Defibrillator/Pacemaker/Monitor, Zoll X Series | FDA |
| mdprc 019 10 12 000 | US Endoscopy | Cytology Brush,used to retrieve cytological cell samples in the gastrointestinal tract | FDA |
| mdprc 018 10 12 000 | Steris Corp | General surgical table,Amsco 3085SP | FDA |
| mdprc 017 10 12 000 | Biomet Inc | Biomet Juggerknot in Guide Punch | FDA |
| mdprc 016 10 12 000 | BD Biosciences | BD FACS 7-color Setup beads, for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software | FDA |
| mdprc 001 10 12 000 | Terumo Cardiovascular Systems Corporation | Terumo Advanced Perfusion System 1 System 1 Base and Electronic O2 Blender/Analyzer | FDA |
| mdprc 178 09 12 000 | Lucero Medical | Bone Matrix Implants, Synthetic, Enduramesh Corpectomy Spacer Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112080 |
| mdprc 177 09 12 000 | Kimberly Clark Health Care | Warming Units, Model 1000 Patient Warming System Control Units | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111119 |
| mdprc 176 09 12 000 | GE Healthcare | Diagnostic imaging systems, Advantage Worksation version 4.2 and 4.3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108540 |
| mdprc 156 09 12 000 | Tedan Surgical Innovations Llc | fixation, Sterile Distraction Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112010 |
| mdprc 155 09 12 000 | Spacelabs Healthcare Inc | Monitor, Ultraview DM3 Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112079 |
| mdprc 154 09 12 000 | Philips Healthcare | radiographic, DigitalDiagnost Systems with M Cabinet | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111935 |
| mdprc 153 09 12 000 | OMNIlife science | Apex Knee System Modular Tibia Augment | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112024 |
| mdprc 152 09 12 000 | Instrumentation Laboratory | Automated Coagulation Analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111953 |
| mdprc 151 09 12 000 | GE Healthcare | Radiographic Units, Mobile, Optima XR200amx and XR220amx Mobile Radiographic Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112107 |
| mdprc 150 09 12 000 | GE Healthcare | Automatic Mobile X-Ray, Optima Mobile X-ray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110854 |
| mdprc 149 09 12 000 | Capsule Tech Inc | Component in the DataCaptor Connectivity System, Capsule Neuron Docking Station | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111859 |
| mdprc 148 09 12 000 | Biosense Webster Inc. | catheter-based atrial and ventricular mapping, CARTO 3 V1.05 System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88917 |
| mdprc 135 09 12 000 | Medtronic Xomed Inc | Monitor, Nerve Integrity Monitor 3.0 Patient Interfaces | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112330 |
| mdprc 134 09 12 000 | Hospira Inc | Injectors, Medication/Vaccine, 30 mL Sterile Empty Vials and Injectors Used with PCA Pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112021 |
| mdprc 133 09 12 000 | Exactech | Implantation of Novation Hip system components, NOVATION MODULAR DRILL BIT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110251 |
| mdprc 110 09 12 000 | Sunquest Information Systems Inc | Information Systems, Data Management, Sunquest Laboratory | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111675 |
| mdprc 109 09 12 000 | Steris Corp | SYSTEM 1E Liquid Sterilant Processing System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111958 |
| mdprc 108 09 12 000 | Siemens Medical Solutions | Mobile X-Ray System, Siemens Mobilett Mira | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112355 |
| mdprc 107 09 12 000 | RaySearch Laboratories AB | Radiotherapy, RayStation Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112152 |
| mdprc 106 09 12 000 | JK Products & Services, Inc | Ultraviolet Radiation, SUN|DASH RADIUS 252 tanning system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111444 |
| mdprc 105 09 12 000 | Custom Medical Specialties, Inc | bottle PVP Prep Solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111924 |
| mdprc 104 09 12 000 | Breg Inc, An Orthofix Company | insulation barrier, Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98803 |
| mdprc 103 09 12 000 | Becton Dickinson & Co. (BD) | IVD, GeneOhm Cdiff Assay , GeneOhm MRSA ACP Assay, GeneOhm VanR Assay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110805 |
| mdprc 102 09 12 000 | Bard Pcripheral Vascular (BPV) | Bard Foley procedural trays packaged in breather bags | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111691 |
| mdprc 101 09 12 000 | AmeriWater | Water Purification Systems, Reverse Osmosis, Hemodialysis, Portable, Model MRO Portable RO+ Reverse-Osmosis Systems. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111946 |
| mdprc 100 09 12 000 | Aesculap Inc | Fixation, Aesculap S4 Element 4.5mm Polyaxial Screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111846 |
| mdprc 099 09 12 000 | Toshiba Corp Medical Systems Co Ltd | Whole Body X--ray Scanner, CT system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84557 |
| mdprc 098 09 12 000 | Steris Corp | Quick Connect device connects endoscopes to the sterilization tray, QKC1692E | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111699 |
| mdprc 097 09 12 000 | Mediline Industries, Inc | cutting and coagulation of soft tissue, Electrosurgical | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111229 |
| mdprc 096 09 12 000 | GE Medical Systems | OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111483 |
| mdprc 095 09 12 000 | Exactech | Optetrak Logic Total Knee System, OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109647 |
| mdprc 094 09 12 000 | Encore Medical, Lp | more closely match the kinematics of the knee, 3DKnee e+ Tibial Insert, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111744 |
| mdprc 093 09 12 000 | Cook Medical | Stents, Vascular, 5 Fr Zilver 518 Vascular Self-Expanding Stents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108136 |
| mdprc 092 09 12 000 | Capintec Inc | measurement of organ uptake and circulating radioactivity, Capintec Captus 3000 Thyroid Uptake System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112193 |
| mdprc 091 09 12 000 | Atlas Spine | Screwdrivers, Bone, Apelo Modular Screwdrivers Used with Apelo Pedical Screw Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111339 |
| mdprc 090 09 12 000 | Advanced Sterilization Products | High Level Disinfectant Solutionm, CIDEX OPA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112036 |
| mdprc 089 09 12 000 | Toshiba Corp Medical Systems Co Ltd | Scanner, Computed Tomography, X-Ray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111873 |
| mdprc 088 09 12 000 | Terumo Cardiovascular Systems Corporation | Pumps, Extracorporeal Perfusion | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111352 |
| mdprc 087 09 12 000 | Sunquest Information Systems Inc | Information Systems, Data Management, Laboratory, Laboratory Information System Software Using Microbiology Result Entry | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111472 |
| mdprc 086 09 12 000 | Stryker Medical | transport a seated patient, Powered Mobility Offers Versatility (M®V)TM Chair1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108686 |
| mdprc 085 09 12 000 | Philips Medical Systems | Positron Emission Tomography (PET) and X-ray Computed Tomography | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111947 |
| mdprc 084 09 12 000 | Medtronic | Radiographic/Fluoroscopic Units, Mobile, O-Arm Imaging Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111068 |
| mdprc 083 09 12 000 | Hitachi Medical Corp | Software controlled MRI devices, Hitachi Echelon MRI System/Oasis MR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111915 |
| mdprc 082 09 12 000 | GE Medical Systems | picture archiving and communications system, OEC InstaTrak 3500 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111580 |
| mdprc 081 09 12 000 | GE Medical Systems | fluoroscope X-ray, GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111583 |
| mdprc 080 09 12 000 | GE Medical Systems | Image-intensified fluoroscopic x-ray system, GE OEC 9800 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111381 |
| mdprc 079 09 12 000 | Exactech | Optetrak Comprehensive Knee Systems, LOGIC Proximal Tibial Spacer Size 2.5 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109896 |
| mdprc 078 09 12 000 | Canon Inc | Canon Solid Stale X-ray Imaqer (Flat Panel/Digital Imager) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111794 |
| mdprc 077 09 12 000 | Beckman Coulter Inc | IVD, UniCel DxI and DXC Immunoassay Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111461 |
| mdprc 076 09 12 000 | Afassco Inc | cover a fingertip bandage, finger cots | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111455 |
| mdprc 075 09 12 000 | Varian Medical Systems | Information Systems, Data Management, Oncology, Radiotherapy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111025 |
| mdprc 074 09 12 000 | Synthes Inc | Bone Matrix Implants, Hemostatic Bone Putty | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111111 |
| mdprc 073 09 12 000 | stryker spine | Distract the disc space, Reliance AL Implant Blocker | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110439 |
| mdprc 072 09 12 000 | Siemens Medical Solutions | Information Systems, Data Management, Cardiology, syngo Dynamics Servers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111087 |
| mdprc 071 09 12 000 | Siemens Healthcare Diagnostics | IVD, syngo(R) Lab Data Manager | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110419 |
| mdprc 070 09 12 000 | SenTec AG | Digital Monitoring System, SenTec, V-Sign"2 Sensors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111100 |
| mdprc 069 09 12 000 | Philips Medical Systems | Computed Tomography Scanners, The Brilliance 64 and Ingenuity CT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111235 |
| mdprc 068 09 12 000 | Philips Healthcare | Radiographic Systems, Digital, Essenta DR Compact Digital Radiography Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111267 |
| mdprc 067 09 12 000 | Philips Healthcare | Radiographic/Fluoroscopic Systems, Easy Diagnost Classic-Stationary x-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111064 |
| mdprc 066 09 12 000 | Nico Corp | Access to neurological tissues, BrainPath Sheath | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111098 |
| mdprc 065 09 12 000 | Maquet Cardiopulmonary AG | Cannulae, Arterial, Pediatric Arterial Cannulae | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110719 |
| mdprc 064 09 12 000 | Institut Straumann | Dental implant suprastructure, Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111078 |
| mdprc 063 09 12 000 | GE Healthcare | Portable, OEC 8800 Mobile Fluoroscopic X-ray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111739 |
| mdprc 062 09 12 000 | Depuy Orthopaedics, Inc | Implants, Altrx" Altralinked" Polyethylene liners | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111266 |
| mdprc 061 09 12 000 | DePuy International Limited | Prostheses, Various Custom Implants | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111674 |
| mdprc 060 09 12 000 | CareFusion.. | Infusion Pumps, Model 8100 Alaris Pump Modules | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89956 |
| mdprc 059 09 12 000 | CareFusion.. | Infusion Pumps, Alaris Pump Module Model 8100 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111240 |
| mdprc 057 09 12 000 | Sunrise Medical | Padded, swing-away armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110756 |
| mdprc 056 09 12 000 | stryker spine | LUXOR RETRACTOR BASE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111265 |
| mdprc 055 09 12 000 | Medical Specialties Distributors | Infusion Pump Administration Sets, Medstream Universal Administration Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111584 |
| mdprc 053 09 12 000 | Greiner Bio-One Inc | Tubes, Blood Collection, 3 mL 9NC Coagulation Tubes Containing Sodium Citrate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111118 |
| mdprc 052 09 12 000 | Finapres Medical Systems | Recorders, Electronic Storage, Data, Blood Pressure, Portapres Ambulatory Continuous Noninvasive Blood Pressure Monitors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110979 |
| mdprc 051 09 12 000 | Encore Medical, Lp | bone screw, djo surgical6.5 mm cancellous bone screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111018 |
| mdprc 050 09 12 000 | Apheresis Technologies, Inc | Separators, Plasma, Model PP-04a Plasma Pumps Used with Asahi Plasmaflo Plasma Separators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111049 |
| mdprc 047 09 12 000 | TransEnterix | Clip Appliers, Gastrointestinal, Endoscopic, SPIDER Surgical System Flexible Clip Appliers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111090 |
| mdprc 046 09 12 000 | Steris Corp | Mechanical washer, RELIANCE® 130 and 130L CART WASHER | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110984 |
| mdprc 045 09 12 000 | Smith & Nephew inc | Dyonics Electroblade Resector, Full Radius Blade, BONECUTTER | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111171 |
| mdprc 044 09 12 000 | SCC Soft Computer | Information Systems, Data Management, Laboratory, SA INST Applications Used with SoftLab Software and Specific Sysmex Instruments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109709 |
| mdprc 043 09 12 000 | ICU Medical, Inc | Stopcocks, High-Pressure Stopcocks | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110877 |
| mdprc 042 09 12 000 | GE Medical Systems | fluoroscopic, spot-film imaging, OEC MiniView 6800 Mobile, UroView 2800 and OEC 9800 Plus | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110685 |
| mdprc 041 09 12 000 | Beekley Corp | Markers, Skin, Medical SPOTS Digital Skin Markers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110840 |
| mdprc 040 09 12 000 | Aesculap Inc | Aesculap SIBD 4 degree Trial Implant and Aesculap SIBD 9 degree Trial Implant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111198 |
| mdprc 039 09 12 000 | Abbott Point of Care | Quantitatively measure, I-STAT EG7+ Cartridge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110354 |
| mdprc 037 09 12 000 | The Anspach Effort, Inc. | Burs, Surgical, Bone Cutting Burs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110229 |
| mdprc 036 09 12 000 | Neusoft Medical Systems | CT Scanner, NeuViz 16 Multi-Slice CT Scanner System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110741 |
| mdprc 035 09 12 000 | Mallinckrodt Baker | Sterile plastic tube, Handi-Fil Disposable Syringe Fill Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89069 |
| mdprc 034 09 12 000 | Hospira Inc | Intravenous Administration Sets, 100 mL x 77-Inch Convertible Pin Burette Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111089 |
| mdprc 033 09 12 000 | Getinge Disinfection AB | Sterilizing Units, 9100 Series Electrically Heated Washer-Disinfectors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109621 |
| mdprc 032 07 12 001 | Ethicon Inc | Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109783 |
| mdprc 090 08 12 000 | Synthes Inc | spinal fixation, Universal Spinal System Lamina Hooks | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110226 |
| mdprc 089 08 12 000 | OrthoPediatrics Corp | Plates, Bone, 4.5 mm Right Locking Contoured Compression 8-Hole Plates Used with PediLoc Femur Locking Plate Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110311 |
| mdprc 088 08 12 000 | Exactech Inc. | Optetrak Cemented Trapezoid Tibial Tray and Optetrak Rotating Bearing Knee Tibial Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109674 |
| mdprc 087 08 12 000 | Varian Medical Systems | radiotherapy, Eclipse Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110464 |
| mdprc 086 08 12 000 | Philips Healthcare | Computed Tomography, X-Ray Systems, Various Brilliance and Ingenuity Computed Tomography Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110763 |
| mdprc 085 08 12 000 | Hitachi Medical Corp | Scanning Systems, Computed Tomography, Scenaria Computed Tomography System Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110356 |
| mdprc 084 08 12 000 | GE Medical Systems | Image-intensified fluoroscopic x-ray system, OEC FluoroTrak 9800 Plus | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79254 |
| mdprc 081 08 12 000 | Bridgepoint Medical | Stingray Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110688 |
| mdprc 080 08 12 000 | Alere San Diego | Reagents, Triage Tox+MTD Drug Screen | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110155 |
| mdprc 079 08 12 000 | AGFA Corp. | Information Systems, IMPAX Cardiovascular Reporting Non-Invasive Vascular Results Management Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110871 |
| mdprc 013 08 12 000 | Terumo Cardiovascular Systems Corporation | The Terumo Advanced Perfusion System 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108925 |
| mdprc 012 08 12 000 | Smiths Medical | Medfusion® Syringe Infusion Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107652 |
| mdprc 011 08 12 000 | LMA North America Inc | Detectors, Esophageal Intubation Detectors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110279 |
| mdprc 010 08 12 000 | Integra Limited | Endoscopic Instruments,Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110714 |
| mdprc 009 08 12 000 | Gulf Fiberoptics, Inc | GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110426 |
| mdprc 008 08 12 000 | Stingray Surgical Products, LLC | general surgical procedures, Bipolar Forceps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109874 |
| mdprc 007 08 12 000 | Spacelabs Healthcare Inc | Monitor, Xprezzon Bedside Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110571 |
| mdprc 006 08 12 000 | Kimberly Clark Health Care | MicroCool Breathable Impervious Surgical Gown | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110687 |
| mdprc 005 08 12 000 | GE Healthcare | Physiologic Monitor Modules, Invasive Blood Pressure Care Cables | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109880 |
| mdprc 004 08 12 000 | Etac | wheeled walkers , Etac® Ono Walker, Etac® Avant Walker, and Etac® Salsa Walker | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108163 |
| mdprc 003 08 12 000 | DeRoyal Industries Inc | Surgical Kits and Trays, GEO-MED TOTAL KNEE PACK PGYBK | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110698 |
| mdprc 002 08 12 000 | Abbott Molecular Inc Sub Abbott Laboratories | Bar Code Scanner User's Guide | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110232 |
| mdprc 076 06 11 001 | CMS Inc Div Elekta AB | Radiation Treatment Planning Systems, XiO | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98830 |
| mdprc 111 07 12 000 | PSC Industries Inc | Electrosurgical Irrigating Bipolar Forceps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110247 |
| mdprc 110 07 12 000 | Philips Healthcare | Defibrillator/Pacemakers, Model M3536A HeartStart MRx Monitor/Defibrillators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110296 |
| mdprc 109 07 12 000 | Integra LifeSciences Corporation | Catheter Flush Valves, Pudenz Flushing Valves with Integral Connectors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109901 |
| mdprc 108 07 12 000 | Respironics Inc | Respironics Trilogy systems,Ventilators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110401 |
| mdprc 107 07 12 000 | CareFusion. | Infusion Pumps, Model 8015 Alaris PC Unit Infusion Pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109684 |
| mdprc 017 09 11 001 | Hospira Inc | Docking Stations, GemStar Infusion Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102851 |
| mdprc 070 07 12 000 | Terumo Cardiovascular Systems Corporation | Perfusion, Advanced Perfusion System 1 Bases | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108194 |
| mdprc 069 07 12 000 | Terumo Cardiovascular Systems Corporation | Perfusion,Terumo Advanced Perfusion System 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110340 |
| mdprc 068 07 12 000 | Smiths Medical | Warming Units, HOTLINE 3 Blood and Fluid Warmers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110397 |
| mdprc 067 07 12 000 | GE Healthcare | Image Processing System, GE Advantage CT/PET Fusion | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108503 |
| mdprc 066 07 12 000 | Edwards Lifesciences | Suction Kits, Rigid Suction Wand Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=82771 |
| mdprc 065 07 12 000 | Cardiovascular Systems, Inc | Stealth 360-degree Orbital Atherectomy Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110453 |
| mdprc 064 07 12 000 | Terumo Cardiovascular Systems Corporation | Central Control Monitor , Advanced Perfusion System 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110370 |
| mdprc 063 07 12 000 | Encision Inc | Electrodes, AEM Disposable Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108356 |
| mdprc 062 07 12 000 | Civco Medical Instruments Inc | Sensor,electromagnetic sensor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109099 |
| mdprc 061 07 12 000 | CareFusion. | Ventilators, EnVe Ventilators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110307 |
| mdprc 057 07 12 000 | Invacare Corporation | Power Wheelchair, TDX SP, TDX SR, TDX SI Power Wheelchair | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108412 |
| mdprc 056 07 12 000 | Elekta/IMPAC | Oncology Information Systems , MOSAIQ | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110188 |
| mdprc 055 07 12 000 | Thayer Medical Corporation | Inhalers, AirLife MiniSpacer Metered Dose Inhaler Adapters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110105 |
| mdprc 054 07 12 000 | Pride Mobility Products Ltd | wheelchair, Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95926 |
| mdprc 053 07 12 000 | GE Medical Systems | Image Processing System, InstaTrak with Multiple Dataset Navigation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109866 |
| mdprc 036 07 12 000 | Polymer Technology Systems, Inc. | Test strips, PTS Panels Creatinine test strips | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109606 |
| mdprc 034 07 12 000 | Salter Labs | Delivery of Anesthesia, Adult Divided Cannula end tidal Co2 sampling w/male luer-lock connector | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110043 |
| mdprc 033 07 12 000 | Medical Components, Inc | Polyurethane Catheter, 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110003 |
| mdprc 031 07 12 000 | Zimmer inc | Drills, 6 mm Bigliani/Flatow Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drills with Stops | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109571 |
| mdprc 030 07 12 000 | Terumo Cardiovascular Systems Corporation | Cannulae, Sarns Antegrade Cardioplegia Cannulae | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108818 |
| mdprc 029 07 12 000 | Alere San Diego` | Reagents, Immunoassay, Various Triage Immunoassay Reagents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109501 |
| mdprc 152 06 12 000 | Stryker Endoscopy | Handpiece, Formula 180 Shaver Hand Control | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109573 |
| mdprc 151 06 12 000 | Medtronic Navigation Inc | Mobile x-ray system , 0-arm® Imaging System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108856 |
| mdprc 150 06 12 000 | Hartmann USA, Inc | Hartmann Econolux Sterile Gauze sponge and Sterile Premium gauze sponge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109341 |
| mdprc 149 06 12 000 | Genzyme Diagnostics Div Genzyme Corp | Films, Seprafilm Adhesion Barriers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109888 |
| mdprc 148 06 12 000 | Accumetrics Inc | Whole blood assay, VerifyNow P2Y12 assay device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109704 |
| mdprc 134 06 12 000 | Stryker Instruments | Barrier, Hytrel Zipper Toga | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109236 |
| mdprc 133 06 12 000 | Non-Invasive Monitoring Systems, Inc | Acceleration Therapeutics device, Exer-Rest device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109263 |
| mdprc 132 06 12 000 | Ultradent Products, Inc | Syringe, Peak SE Primer Refill | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109878 |
| mdprc 131 06 12 000 | Philips Healthcare | Stationary Fluoroscopic system, Easy Diagnost | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109279 |
| mdprc 130 06 12 000 | Arrow International Inc | Pressure Injectable Central Venous Catheter, 7FR 3-Lumen Arrowg+ard Blue Plus® | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109883 |
| mdprc 129 06 12 000 | App Pharmaceuticals Llc | HEPARIN LOCK FLUSH SOLUTION | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97659 |
| mdprc 106 06 12 000 | Vygon UK Ltd | Syringes, Flush Heparin Lock Flush Syringes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109541 |
| mdprc 105 06 12 000 | GE Healthcare | Anesthesia machine, Aestiva/5 7900 SmartVent | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108604 |
| mdprc 092 06 12 000 | Sigma International LLC | Spectrum VOLUMETRIC INFUSION PUMP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107879 |
| mdprc 091 06 12 000 | Philips Medical Systems | Computed Tomography X-Ray Systems, The Brilliance iCT and iCT SP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109268 |
| mdprc 090 06 12 000 | GE Medical Systems | Digital Radiographic System, Definium 8000, Silhouette FC(Proteus XR/a) and Revolution XR/d | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=51230 |
| mdprc 088 06 12 000 | Captiva Spine, Inc | Lumbar spine, Spinal Invervetebral Disc Space Orthosis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109497 |
| mdprc 087 06 12 000 | MicroAire Surgical Instruments | Liposuction procedures, Lipofilter 3000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109241 |
| mdprc 065 06 12 000 | Spacelabs Healthcare Inc | Monitor, Xprezzon Bedside Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109489 |
| mdprc 064 06 12 000 | Excelsior Medical Corp | Infusion therapy, Heparin Lock Flush | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109178 |
| mdprc 058 06 12 000 | Invacare Corporation | Walkers, Knee Walkers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108408 |
| mdprc 054 06 12 000 | Water Pik, Inc | Sinus washing, Water Pik Sinusense battery operated | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108365 |
| mdprc 053 06 12 000 | Stryker Orthopaedics | Restoration HA cementless Hip System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107822 |
| mdprc 052 06 12 000 | Siemens Medical Solutions | e.cam Emission Computed Tomography Systems and Symbia E Series SPECT System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108691 |
| mdprc 051 06 12 000 | Moog Inc | Curlin® Infusion Administration Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109321 |
| mdprc 050 06 12 000 | Genesys Orthopedic Systems | Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108603 |
| mdprc 049 06 12 000 | Covidien | Syringes, Monoject Insulin Safety Syringes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109368 |
| mdprc 048 06 12 000 | CaridianBCT Inc | Spectra Optia Apheresis System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109094 |
| mdprc 047 06 12 000 | ConMed Corporation | Altrus Energy Source, Tissue Fusion Energy Source | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109155 |
| mdprc 046 06 12 000 | ConMed Corporation | Altrus Thermal Tissue Fusion | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109176 |
| mdprc 045 06 12 000 | Alphatec Spine Inc | SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108936 |
| mdprc 015 06 12 000 | Philips Medical Systems | Ingenuity TF PET/MRI System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109141 |
| mdprc 014 06 12 000 | Medical Components, Inc | 8F Plastic Dignity Mid-Sized CT Port, ChronoFlex Polyurethane Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109257 |
| mdprc 013 06 12 000 | Diamedix Corporation | ENA-6 Screen Enzyme Immunoassay Test Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108435 |
| mdprc 012 06 12 000 | Biosense Webster Inc A Johnson & Johnson Co | EZ STEER Catheter, Cardiovascular catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=70961 |
| mdprc 011 06 12 000 | Arcadia Medical Corporation | Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck, Flange Tracheostomy Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108664 |
| mdprc 007 06 12 000 | Vascular Solutions Inc | Catheters, GuideLiner V2 Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109189 |
| mdprc 006 06 12 000 | College Park Industries, Inc | Celsus prosthetic foot | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108756 |
| mdprc 005 06 12 000 | CMS Inc Div Elekta AB | XiO Radiation Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108860 |
| mdprc 004 06 12 000 | Captiva Spine, Inc | Drill Bits for Cervical Plate System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109147 |
| mdprc 003 06 12 000 | Apheresis Technologies, Inc | PlasmaPro Plasma Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108552 |
| mdprc 002 06 12 000 | Pharmaceutical Innovations, Inc | Other-Sonic Generic Ultrasound Transmission Gel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108813 |
| mdprc 001 06 12 000 | Baxa Corp | Abacus TPN Calculating Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=81907 |
| mdprc 076 05 12 000 | Varian Medical Systems | Radiotherapy Systems, TrueBeam and TrueBeam STx | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108735 |
| mdprc 075 05 12 000 | MEDDEV USA, INC | 50 Portal Vein Cannula, infusion | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109248 |
| mdprc 074 05 12 000 | Fresenius Medical Care | Naturalyte Acid Concentrate for bicarbonate Dialysis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108033 |
| mdprc 073 05 12 000 | Ellman International, Inc | Pelleve hand pieces | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109119 |
| mdprc 061 05 12 000 | Thera Test Laboratories, Inc | Diagnosis of Rheumatoid Arthritis (RA), RF IgA Calibrator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108288 |
| mdprc 060 05 12 000 | North Coast Medical Inc | Exercisers, Norco Shoulder Pulleys | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108183 |
| mdprc 059 05 12 000 | Captiva Spine, Inc | Spinal Intervertebral body Fixation Orthosis, SmartLOX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109124 |
| mdprc 058 05 12 000 | Terumo Cardiovascular Systems Corporation | CAPIOX FX Hollow Fiber Oxygenator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108803 |
| mdprc 057 05 12 000 | Steris Corp | Evolution steam sterilizers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109080 |
| mdprc 056 05 12 000 | Mitaka USA, Inc | Surgical instruments, Point Setter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=83534 |
| mdprc 055 05 12 000 | Haemacure Corpo | HemaSyst, Dual cannula Tip with Adapter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108601 |
| mdprc 054 05 12 000 | GF Health Products | LUMEX A Graham-Field Brand, Bed End Sert | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108355 |
| mdprc 053 05 12 000 | CaridianBCT Inc | Trima Accel Automated Blood Collection System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109058 |
| mdprc 052 05 12 000 | Zimmer inc | Zimmer® 4.1 Trabecular Metal" Dental Implant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108234 |
| mdprc 051 05 12 000 | O'Ryan Industries Inc | Dental curing light, DISPOSA-SHIELD | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108697 |
| mdprc 050 05 12 000 | MichClone Associates, Inc | BioTron Sickle Cell Reagent Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107977 |
| mdprc 049 05 12 000 | International Medsurg Connection | Dual X-Ray Gauze | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108705 |
| mdprc 048 05 12 000 | CaridianBCT Inc | Caridian BCT COBE Spectra System Blood Warmer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108941 |
| mdprc 037 05 12 000 | Siemens Medical Solutions | Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108458 |
| mdprc 036 05 12 000 | Sandhill Scientific Inc | InSIGHT Gastrointestinal Motility System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86301 |
| mdprc 019 05 12 000 | Wright Medical Technology Inc | VALOR(TM) TTC FUSION, INSTRUMENT KIT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108522 |
| mdprc 018 05 12 000 | Siemens Medical Solutions | ARTISTE, ONCOR and PRIMUS Linear Accelerator systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108392 |
| mdprc 017 05 12 000 | Hospira Inc | LifeShield Primary Plumset | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108703 |
| mdprc 015 05 12 000 | Stanley Healthcare Solutions | Monitors, Micro-Tech Informer Plus Silver Monitors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106247 |
| mdprc 014 05 12 000 | Ogenix Corporation | Transdermal continuous oxygen therapy, EPIFLO | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108599 |
| mdprc 013 05 12 000 | Churchill Medical Systems | Latex-Free Winged Infusion Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108644 |
| mdprc 012 05 12 000 | Biomet Inc | Trochanteric Nail. Long | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108656 |
| mdprc 150 04 12 000 | Alere LTD | Reagents, Alere Triage CardioProfiler Panel | FDA |
| mdprc 148 04 12 000 | Stanley Healthcare Solutions | Monitor, UMP Personal Sentry Deluxe Pull String Monitor | FDA |
| mdprc 147 04 12 000 | Philips Healthcare | Information system, monitor, eCareManager System | FDA |
| mdprc 146 04 12 000 | Medical Information Technology, Inc. | Laboratory instrument, software, MEDITECH Anatomical Pathology Software | FDA |
| mdprc 145 04 12 000 | Ortho-Clinical Diagnostics | Chemistry Systems, VITROS | FDA |
| mdprc 144 04 12 000 | Aesculap Inc | Screws, spinal, Quintex Cervical Plating System - Screws | FDA |
| mdprc 143 04 12 000 | Winco, Inc. | Chairs, Elite Care Cliner | FDA |
| mdprc 142 04 12 000 | GE Healthcare | X- Ray, GE Automatic Mobile X-Ray Systems | FDA |
| mdprc 141 04 12 000 | Fresenius Medical Care | Dialysis, Peritoneal, Fresenius Liberty Cycler | FDA |
| mdprc 140 04 12 000 | Terumo Cardiovascular Systems Corporation | Perfusion, Sarns Modular Perfusion System 8000 | FDA |
| mdprc 139 04 12 000 | Biomet Inc | Joint prosthesis, hip, Selex M2A Magnum Modular Head, 40 mm | FDA |
| mdprc 138 04 12 000 | Abbott Laboratories Inc | Reagents, ARCHITECT/AEROSET Activated Aspartate Aminotransferase | FDA |
| mdprc 137 04 12 000 | Alere LTD | Reagents, Triage TOX Drug Screen (MTD) Panel | FDA |
| mdprc 136 04 12 000 | Boston Scientific Ltd | Monitor, Latitude Patient Management System Communicator | FDA |
| mdprc 135 04 12 000 | Biomet Inc | Plate prosthesis, Optilock | FDA |
| mdprc 134 04 12 000 | Biomet Inc | Prosthesis, MAK OSS No Head Lock Pin | FDA |
| mdprc 133 04 12 000 | Advanced Bionics Corp. | Stimulator, The Precision Spinal Cord Stimulator System | FDA |
| mdprc 132 04 12 000 | Synaptic Corp | Stimulator, cranial , Synaptic | FDA |
| mdprc 131 04 12 000 | Stryker Howmedica Osteonics Corp | Implants, MEDPOR PLUS | FDA |
| mdprc 130 04 12 000 | Teva Pharmaceuticals USA, Inc. | Storage & collection devices, organ preservation fluid (for transport and storage), ViaSpan Cold Storage Solution 1000mL Bag | FDA |
| mdprc 129 04 12 000 | DePuy International Limited | Prostheses, Joint, Knee, PFC Steinman Pin/Drill Pack Sterile | FDA |
| mdprc 128 04 12 000 | KCI USA Inc | Mobility Assist & Trainer, Zuma Mobility System | FDA |
| mdprc 127 04 12 000 | Abbott Laboratories Inc | IVDs clinical chemistry, Instrumentation, Clinical Chemistry Total Bilirubin | FDA |
| mdprc 126 04 12 000 | North Coast Medi-Tek | Shower Bench, Norco Folding Shower Bench | FDA |
| mdprc 124 04 12 000 | Beckman Coulter Inc | Reagents, Synchron Ammonia (AMM) Reagent | FDA |
| mdprc 084 04 12 000 | Roche Diagnostics Corp | IVD, ACCU-CHEK Aviva Nano Blood Glucose Meter | FDA |
| mdprc 079 04 12 000 | ScottCare Corp | Electrocardiography, TeleSentry, Multi-parameter Ambulatory Telemetry | FDA |
| mdprc 078 04 12 000 | Moog Inc | Ambulatory Pumps , Curlin Infusion Administration Set | FDA |
| mdprc 077 04 12 000 | Baxa Corp | Feeding systems, Baxa EVA TPN bags | FDA |
| mdprc 076 04 12 000 | DeRoyal Industries Inc | Needle Sets, Umbilicup | FDA |
| mdprc 075 04 12 000 | Boston Scientific Corporation | Catheters, Boston Scientific, IMAGER II Urology Torque Catheter | FDA |
| mdprc 074 04 12 000 | Siemens Healthcare Diagnostics | Informatics Systems, EasyLink Informatics Systems | FDA |
| mdprc 073 04 12 000 | Biocare Medical Llc | IVD, Vina Green Chromogen Kit | FDA |
| mdprc 072 04 12 000 | Siemens Medical Solutions | X-Ray, Siemens Axiom Luminos dRF solid state x-ray imager | FDA |
| mdprc 071 04 12 000 | Siemens Healthcare Diagnostics | Reagents, ADVIA Centaur Cortisol Assay | FDA |
| mdprc 070 04 12 000 | Baxa Corp | Pharmacy compounding system, Exacta-Mix 2400(EM2400) Compounder Operating System | FDA |
| mdprc 069 04 12 000 | Animas Corporation | Insulin Pump , OneTouch(R) Ping(R) Insulin Pump glucose management system | FDA |
| mdprc 068 04 12 000 | Beckman Coulter Inc | IVD, Access Immunoassay Systems | FDA |
| mdprc 067 04 12 000 | Terumo Cardiovascular Systems Corporation | Blood Parameter Monitoring System, CDI 500 Monitor | FDA |
| mdprc 066 04 12 000 | Milabs Bv | Cabinet of x-ray, U-SPECT-II/CT and VECTor/CT cabinet x-ray products | FDA |
| mdprc 065 04 12 000 | Hologic Inc | Viewing images, Hologics SecurView DX workstation | FDA |
| mdprc 064 04 12 000 | Baxa Corp | Intravenous Solution Compounders, Exacta-Mix 2400 Compounder (EM 2400) | FDA |
| mdprc 063 04 12 000 | Siemens Medical Solutions | Magnetic resonance, Siemens MAGNETOM Verio | FDA |
| mdprc 062 04 12 000 | Acumed LLC | Bone Rod, The Polarus Plus Humeral Rod | FDA |
| mdprc 061 04 12 000 | Spinetronics, LLC | Literature, Antalgic-Trak | FDA |
| mdprc 060 04 12 000 | Gendex Dental Systems | Dental X-Ray System, Gendex eXpert DC Intraoral | FDA |
| mdprc 059 04 12 000 | LifeScan, Inc | Monitors, Glucose, OneTouch Verio IQ Blood Glucose Monitoring System Kit | FDA |
| mdprc 055 04 12 000 | CMS Inc Div Elekta AB | Radiation Treatment Planning System, Monaco | FDA |
| mdprc 054 04 12 000 | Philips Medical Systems | Computed tomography, Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems | FDA |
| mdprc 051 04 12 000 | Straumann USA, LLC | Dental implants , Straumann Standard Plus Implant | N/A |
| mdprc 050 04 12 000 | Optovue inc | Ophthalmoscope, Cornea Power Kit (software) | FDA |
| mdprc 049 04 12 000 | Fresenius Medical Care | Hemodialysis, Optiflux F160NRe Hemodialyzer | FDA |
| mdprc 048 04 12 000 | Stryker Medical | Critical Care Bed, Epic | FDA |
| mdprc 047 04 12 000 | Aerolase | laser, Aerolase lasers, FriendlyLight YAG lasers | FDA |
| mdprc 046 04 12 000 | Oridion Capnography Inc | Monitors, patient multi parameter monitor, Oridion CO2 sampling lines and water traps | FDA |
| mdprc 045 04 12 000 | Hamamatsu Corporation | X-ray system, Hamamatsu Microfocus X-ray Source | FDA |
| mdprc 044 04 12 000 | Philips Healthcare | X-Ray System, EasyDiagnost Eleva DRF 4.0 | FDA |
| mdprc 043 04 12 000 | Terumo Cardiovascular Systems Corporation | Heart-Lung Bypass Units, Terumo Advance Perfusion System 1 | FDA |
| mdprc 042 04 12 000 | Biomet Microfixation | Cutting tip, LactoSorb Heat/Contouring Pen | FDA |
| mdprc 041 04 12 000 | Becton Dickinson & Co. (BD) | Bacteriology-Culture, BD BBL ™ Lowenstein-Jensen Medium Deeps | FDA |
| mdprc 040 04 12 000 | Ortho-Clinical Diagnostics | Analyzers, Laboratory, VITROS Chemistry Products dHDL Slides | FDA |
| mdprc 039 04 12 000 | Penlon | Anesthesia Machines, Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display | FDA |
| mdprc 038 04 12 000 | RaySearch Laboratories AB | Radiotherapy, RayStation | FDA |
| mdprc 037 04 12 000 | Philips Medical Systems | X-Ray System, Philips Easy Diagnost Eleva DRF | FDA |
| mdprc 036 04 12 000 | Biomet Microfixation | Plate prosthesis, Bone Plate | FDA |
| mdprc 035 04 12 000 | Becton Dickinson & Co. (BD) | Bacteriology-Culture, Fildes Enrichment | FDA |
| mdprc 034 04 12 000 | Philips Medical Systems | Computed tomography, Brilliance 64 and Ingenuity CT | FDA |
| mdprc 033 04 12 000 | Medtronic Vascular | Endovascular approach, Talent Thoracic Stent Graft System | FDA |
| mdprc 032 04 12 000 | Stryker Howmedica Osteonics Corp | Prothesis, Osteonics Shoulder Glenoid Spanner | FDA |
| mdprc 031 04 12 000 | Christie Medical Holding Inc | Non- invasive electronic visual aid device, VeinViewer | FDA |
| mdprc 030 04 12 000 | Ortho-Clinical Diagnostics | Analyzers, Laboratory, VITROS Chemistry Products ALT Slides | FDA |
| mdprc 029 04 12 000 | Permobil AB | Power wheelchair, Permolock C3 | FDA |
| mdprc 028 04 12 000 | Customed, Inc | Wound Management Tray | FDA |
| mdprc 027 04 12 000 | Siemens Healthcare Diagnostics | Reagents, Immunoassay, ADVIA Centaur Vitamin D Diluent 2-pack | FDA |
| mdprc 026 04 12 000 | Ethicon Endo Surgery Inc | Electrosurgical Units, ENSEAL® 5 mm Diameter Tissue Sealer G2 14 cm & G2 14 cm Length Straight Curved Jaw | FDA |
| mdprc 025 04 12 000 | Leica Microsystems Inc. | Surgical microscope, Swingarm M820/M844 C19 | FDA |
| mdprc 024 04 12 000 | HealthTronics Inc | Thermometers, Thermometers,Temperature Probes, CRYO Care Surgical System | FDA |
| mdprc 023 04 12 000 | Siemens Medical Solutions | linear accelerators systems , Information System, MOSAIQ Oncology | FDA |
| mdprc 022 04 12 000 | Biomet Inc | implantation, screws, Micromax Anchors, Lactosorb Anchors | FDA |
| mdprc 109 03 12 000 | Medtronic MiniMed | Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=46837 |
| mdprc 108 03 12 000 | GE Healthcare | X-ray Imaging Systems, Innova | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104048 |
| mdprc 107 03 12 000 | Integra LifeSciences Corporation | Surgical, EGR (Endoscopic Gastrocnemius Release System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107479 |
| mdprc 106 03 12 000 | Covidien | DUET TRS Loading Units | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107642 |
| mdprc 105 03 12 000 | Beckman Coulter | SYNCHRON CX(r) systems, Immuno-Protein Calibrator Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107339 |
| mdprc 093 03 12 000 | Varian Medical Systems | Nucletron Adapter and Transfer Guide Tube Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107467 |
| mdprc 092 03 12 000 | Stryker | Soft tissue ablators, Reprocessed Mitek Arthroscopic Wand | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107760 |
| mdprc 091 03 12 000 | Stryker Instruments | Bone cement pressurizers, Flat Proximal Pressurizer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106727 |
| mdprc 090 03 12 000 | Mizuho OSI | Orthopedic Systems, Coupler System II | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107701 |
| mdprc 089 03 12 000 | Kerr Corp | Affix a temporary dental, TempSpan CMT Temporary Cement | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107695 |
| mdprc 088 03 12 000 | Invacare Corporation | TDX SP Power Wheelchair | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107440 |
| mdprc 087 03 12 000 | Integra LifeSciences Ltd | Integra CUSA Excel 23 KHz Sterile Tips Rx | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107298 |
| mdprc 086 03 12 000 | CareFusion | Wet PVP-I Preoperative Skin Prep Tray with Powder-Free Esteem Gloves | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107312 |
| mdprc 085 03 12 000 | Varian Medical Systems | Fast Plan Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107542 |
| mdprc 084 03 12 000 | Philips Healthcare | Mult-functional diagnostic X-Ray system, DuoDiagnost | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107027 |
| mdprc 083 03 12 000 | Philips Healthcare | Easy Diagnost Eleva DRF, Fluoroscopic x-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107557 |
| mdprc 082 03 12 000 | Medical Positioning Inc | MPI Rapid Response HUT Table | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107869 |
| mdprc 078 03 12 000 | Visionsense Ltd | Neurological Endoscope, Visionsense Stereoscopic Vision System, VSII | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107711 |
| mdprc 077 03 12 000 | Varian Medical Systems | Radiology, TrueBeam Radiotherapy Delivery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107546 |
| mdprc 076 03 12 000 | Varian Medical Systems | Radiotherapy, Eclipse Treatment Planning Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107551 |
| mdprc 075 03 12 000 | Sorin Group | Monitor, Control, Extracorporeal blood circulation. S5 System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107575 |
| mdprc 074 03 12 000 | SIEMENS | X-ray,Linear Accelerator, Siemens mMLC (ModuLeaf) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107631 |
| mdprc 073 03 12 000 | Siemens Healthcare Diagnostics | IVD, Assay. ADVIA Centaur Intact PTH (iPTH) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105030 |
| mdprc 072 03 12 000 | SIEMENS | X-Ray, Imaging. Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107662 |
| mdprc 071 03 12 000 | Pointcare Technologies, Inc | IVD, Reagent. CD4NOW Gold Pack | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107286 |
| mdprc 070 03 12 000 | Philips Medical Systems | Radiography, Philips MultiDiagnost Eleva | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107690 |
| mdprc 069 03 12 000 | Pelton & Crane | Dental operative unit, Spirit 3000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107682 |
| mdprc 068 03 12 000 | Ormco Corp | Dental, AdvanSync, orthodontic expansion screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106144 |
| mdprc 067 03 12 000 | Microsoft Corporation Health Solutions Group | Data management, Microsoft Amalga UIS 2009 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107082 |
| mdprc 066 03 12 000 | Integra LifeSciences Corporation | CT scanning, Integra InterFix CT Adapter (CTA) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107363 |
| mdprc 065 03 12 000 | Cell Marque Corporation | IVD, Antibody, Cell Marque CD7 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107190 |
| mdprc 064 03 12 000 | Beckman Coulter Inc | IVD, Reagent. ACCESS Ostase | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107395 |
| mdprc 051 03 12 000 | Ion Genius, Inc. | Various muscle stimulation products | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107465 |
| mdprc 050 03 12 000 | Biomet Inc | Prosthesis, knee, Biomet Signature TKA GDE/MDL SET 04-05 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103533 |
| mdprc 049 03 12 000 | Biomet Inc | Impants, knee replacement, OSS AVL Poly Tibial Bushing Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107299 |
| mdprc 048 03 12 000 | Acclarent Inc | Catheters, Inspira AIR Balloon Dilation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107235 |
| mdprc 025 03 12 000 | Siemens Medical Solutions | Radiologiy, Imgaing, Siemens syngo.plaza | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107379 |
| mdprc 024 03 12 000 | Philips Medical Systems | Information Management System, Philips Intellispace Portal | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107164 |
| mdprc 023 03 12 000 | Medisystems Corp | Needle, Hemodialysis, Fistula Needle Set with MasterGuard Ant-Stick Needle Protector. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107478 |
| mdprc 022 03 12 000 | Carl Zeiss Meditec Inc | Imaging, Laser. Microimaging Laser-TIRF and DirectFRAP | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102128 |
| mdprc 021 03 12 000 | B Braun Medical Inc | Infusion pump, Infusomat Space Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107007 |
| mdprc 020 03 12 000 | Kerr Corp | Dental, Fusio Liquid Dentin | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107638 |
| mdprc 019 03 12 000 | AngioDynamics | Infusion System, BENEPHIT CV | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107342 |
| mdprc 018 03 12 000 | BD Diagnostic Systems | Reagents, BBL Lysine Iron Agar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107173 |
| mdprc 185 02 12 000 | Winco, Inc. | Chairs, Premier LifeCare Recliner and Premier Care Recliner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107175 |
| mdprc 184 02 12 000 | Varian Medical Systems | Radiation, Standard and Millennium 52-leaf MLC multileaf collimator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107242 |
| mdprc 183 02 12 000 | Clarity Medical Systems Inc | Ophthalmic, Imaging. Retcam3 & Retcam Shuttle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107470 |
| mdprc 182 02 12 000 | Cardinal Health | Sutures, Presource kits assembled with Ethicon Sutures in new Tyvek packaging | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107172 |
| mdprc 181 02 12 000 | ThermoFisher Scientific | IVD, Oral-Eze (R) Oral Fluid Collection System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106985 |
| mdprc 180 02 12 000 | Siemens Medical Solutions | Radiation, Therapy. ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107337 |
| mdprc 179 02 12 000 | Lab Vision Corporation | IVD, UltraVision Detection Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106997 |
| mdprc 178 02 12 000 | Greiner Bio-One, Inc | Tubes, Blood Collection. LH Lithium Heparin tubes | H:\NCMDR\Recalls\Recalls from ECRI\2012\January\01 |
| mdprc 177 02 12 000 | Corpak MedSystems | Feeding tube. CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107147 |
| mdprc 176 02 12 000 | Alere San Diego | IVD, immunoassays. Strep A Rapid Test Cassette | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106889 |
| mdprc 165 02 12 000 | Spacelabs Healthcare Inc | Patient Monitor, MULTI PARAMETER MONITOR - Spacelabs Ultraview SL Command Module. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106417 |
| mdprc 164 02 12 000 | Varian Medical Systems | 4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106591 |
| mdprc 163 02 12 000 | Newport Medical Instruments Inc | Ventilator. Cable, an accessory to the Newport HT50 ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103824 |
| mdprc 162 02 12 000 | Life Recovery Systems HD | Monitoring of patient temperature, Thermosuit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106096 |
| mdprc 161 02 12 000 | GE Healthcare | Imaging, Transfer, Table. GE SIGNA EXCITE MR SURGICAL OPTION | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106393 |
| mdprc 160 02 12 000 | Elekta Inc | Radiation therapy treatment, Elekta Synergy Imaging System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107177 |
| mdprc 159 02 12 000 | AngioDynamics Inc | Peripheral access, intravenous therapy. Morpheus Smart | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107343 |
| mdprc 158 02 12 000 | AGFA Corp. | Mobile DR X-Ray , DX-D Imaging Package | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107178 |
| mdprc 148 02 12 000 | St. Jude Medical Inc | Therapy, Cardiac Ablation Generator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107008 |
| mdprc 147 02 12 000 | Siemens Medical Solutions | syngo RT Therapist and syngo RT Therapist | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105463 |
| mdprc 143 02 12 000 | SCC Soft Computer | laboratory information system, SoftMic GUI | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105453 |
| mdprc 142 02 12 000 | Philips Healthcare | Fluoroscopy, Radiography. Philips MultiDiagnost Eleva IITV | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106736 |
| mdprc 141 02 12 000 | MAQUET Inc | Magnus Hybrid operating table columns | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105069 |
| mdprc 140 02 12 000 | Linvatec Corp. | Surgery, Tissue Resection. ConMed Linvatec Full Radius Resector | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101116 |
| mdprc 139 02 12 000 | Kerr Corp | Dental cement under the brand name Cement-It and Natural Elegance | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105131 |
| mdprc 138 02 12 000 | Integra LifeSciences Corporation | Bone void filler, Integra OS Osteoconductive Scaffold Putty | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106839 |
| mdprc 137 02 12 000 | Hospira Inc | Syringes, Sodium Chloride Flush Syringes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105642 |
| mdprc 136 02 12 000 | GE Healthcare | Imaging, GE MR Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104146 |
| mdprc 135 02 12 000 | Biomet Microfixation | IQ Intelligent Driver , aid in the implantation of screws | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105380 |
| mdprc 134 02 12 000 | Biomet Inc | Hip and knee joint replacement prostheses , OSS Cemented IM Stem | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105423 |
| mdprc 133 02 12 000 | Toshiba Corp Medical Systems Co Ltd | X-Ray, Computed Tomography, AQUILION ONE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107320 |
| mdprc 132 02 12 000 | Smiths Medical | CADD® High Volume Administration Set, pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106706 |
| mdprc 131 02 12 000 | Siemens Medical Solutions | PRIMUS and MEVATRON Linear Accelerators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106267 |
| mdprc 130 02 12 000 | Philips Medical Systems | Imaging , Positron Emission Tomography, X-ray Computed Tomography. TruFlight Select PET/CT Scanning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107316 |
| mdprc 129 02 12 000 | Orthofix | Manual surgical instrument, Rotating Cutter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107325 |
| mdprc 128 02 12 000 | Lucero Medical | Impant, ENDURAMESH CORPECTOMY SPACER SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106929 |
| mdprc 127 02 12 000 | Heritage Labs International | Collection Kit, Blood specimen collection, TRIAD brand alcohol pads | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105055 |
| mdprc 126 02 12 000 | GE Healthcare | Laboratory, Cabinet x-ray system , CT Scanner, GE eXplore Locus Micro CT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97538 |
| mdprc 125 02 12 000 | European Custom Manufacturing B.V. | Electrode, pacemaker, temporary. Temporary Pacing Wire, BIPOLAR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106845 |
| mdprc 124 02 12 000 | Diagnostica Stago | IVD, reagents, STA - System Control N+P | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107052 |
| mdprc 123 02 12 000 | Bayer Healthcare | Monitor, Physiological, Viterion 100 TeleHealth Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106852 |
| mdprc 122 02 12 000 | Ascension Orthopedics, Inc | Implant, Joint. First Choice Partial Ulnar Head System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106650 |
| mdprc 119 02 12 000 | ZOLL Medical Corp | Defibrillators , Reduced Energy Multi-Function Electrodes, Zoll pedi.padz | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106605 |
| mdprc 118 02 12 000 | Wright Medical Technology Inc | Joint, DYNASTY Biofoam Shell Prostheses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106868 |
| mdprc 117 02 12 000 | Walter Lorenz Surgical, Inc | LORENZ RESORBABLE DISTRACTOR SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=44812 |
| mdprc 116 02 12 000 | Sybron Dental Specialities | Syringes, Dental, Artiste Flowable and Flow Tec | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104069 |
| mdprc 115 02 12 000 | Stellate Systems | Harmonie Software, electroencephalographic, Monitoring System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93867 |
| mdprc 114 02 12 000 | Siemens Medical Solutions | MAMMOMAT Inspiration Full field digital mammographic x-ray system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105375 |
| mdprc 113 02 12 000 | Siemens Medical Solutions | syngo.plaza Image processing system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105379 |
| mdprc 112 02 12 000 | Radiometer America Inc | ICD, Crea Calibration solution | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106824 |
| mdprc 111 02 12 000 | Kimberly-Clark Corporation | Tampons, Kotex Natural Balance Security tampons | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105225 |
| mdprc 110 02 12 000 | Inverness Medical Inc | IVD, West Nile Virus IgM Capture ELISA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=76225 |
| mdprc 109 02 12 000 | DeRoyal Industries Inc | Surgical kits, TRAUMA CRANIOTOMY PACK | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107151 |
| mdprc 108 02 12 000 | DePuy International Limited | DePuy Offset Wire Fixation Bolt used in Ace-Fischer External Fixation System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105036 |
| mdprc 107 02 12 000 | Cytophil, Inc | Dental, Synthetic Grafting Material. Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107165 |
| mdprc 106 02 12 000 | Cardiopulmonary Instrumentation Inc | Transporting, Stainless Steel Patient Transport Stretcher | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101119 |
| mdprc 105 02 12 000 | BD Biosciences | BD 30G1/2" Precision Glide" Needle Needles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106993 |
| mdprc 104 02 12 000 | Advanced Sterilization Products | STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=78821 |
| mdprc 083 02 12 000 | Smith & Nephew inc | Positioning Aids, SPIDER2 Limb Positioner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105688 |
| mdprc 081 02 12 000 | Siemens Healthcare Diagnostics | IVD, ADVIA Centaur CA19-9 Assay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105596 |
| mdprc 080 02 12 000 | Bausch and Lomb, Incorporated | Crystalens® Accommodating Posterior Chamber Intraocular Lens | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105816 |
| mdprc 079 02 12 000 | AngioDynamics Inc | Targeted Renal Therapy Infusion System, Benephit XT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105887 |
| mdprc 078 02 12 000 | A-M Systems, Inc | ViroMax viral/bacterial filter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90493 |
| mdprc 077 02 12 000 | Terumo Cardiovascular Systems Corporation | Surgical, Sarns Sternal Saw Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104231 |
| mdprc 076 02 12 000 | Terumo Cardiovascular Systems Corporation | CDI 101 Hematocrit/Oxygen Saturation Monitoring System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105526 |
| mdprc 075 02 12 000 | Stryker Medical | Beds, mattress. Stryker EMS Stair-PRO | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105384 |
| mdprc 074 02 12 000 | Ossur | Total Knee Junior Prostheses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84735 |
| mdprc 073 02 12 000 | Ortho-Clinical Diagnostics | Reagents, Clinical Chemistry, VITROS Chemistry Products | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106485 |
| mdprc 072 02 12 000 | Midmark Corp | Sterilizing Units, Midmark M11 Ultra Steam Sterilizer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105922 |
| mdprc 071 02 12 000 | Maquet Cardiopulmonary AG | QUADROX iD PEDIATRIC -OXYGENATOR | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106185 |
| mdprc 070 02 12 000 | Kerr Corporation | Artiste Maverick Tint | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105793 |
| mdprc 069 02 12 000 | DeRoyal Industries Inc | Surgical DeRoyal Surgical Kits and trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106645 |
| mdprc 068 02 12 000 | Biosense Webster Inc | Diagnostic/Ablation Catheter, EZ Steer ThermoCool Nav | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106361 |
| mdprc 067 02 12 000 | Biomet Inc | orthopedic reconstruction, Artificial Ligament Fixation Device, Toggleloc | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=72047 |
| mdprc 066 02 12 000 | Beckman Coulter Inc | AU Clinical Chemistry Analyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106792 |
| mdprc 065 02 12 000 | Alere LTD | Analyzer, IVD, Alere Cholestech LDX System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105233 |
| mdprc 064 02 12 000 | Stryker Orthopaedics | Various Rasp and Broach Handles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106411 |
| mdprc 063 02 12 000 | SIEMENS | Radiological image processing system, syngo Imaging XS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105377 |
| mdprc 062 02 12 000 | Henry Schein, Inc | Maxcem Elite Refill Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105261 |
| mdprc 061 02 12 000 | Nurse Assist, Inc | Urethral Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105373 |
| mdprc 060 02 12 000 | Ascent Healthcare Solutions | Surgery, Arthroscopic shaver blades. DYONICS, STRYKER, LINVATEC Arthroscopic Blades and Burrs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100887 |
| mdprc 046 02 12 000 | Vital Signs Inc A GE Healthcare Co | Broselow/Hinkle Pediatric Emergency System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106353 |
| mdprc 045 02 12 000 | Varian Medical Systems | Therapy, X-ray collimator, The Varian Millennium Collimator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107038 |
| mdprc 044 02 12 000 | Toshiba Corp Medical Systems Co Ltd | Imaging, DRAD-3000E Radrex-i X-ray System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107036 |
| mdprc 043 02 12 000 | Kimberly Clark Health Care | MIC Gastroenteric Feeding Tubes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106739 |
| mdprc 042 02 12 000 | Edwards Lifesciences | Vigilance II Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84048 |
| mdprc 041 02 12 000 | Volcano Corp | Guidewire, Volcano FloWire Doppler Guidewire | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106630 |
| mdprc 040 02 12 000 | Vision-Sciences, Inc. | Lithium-Ion Rechargeable Batteries and Battery Chargers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106518 |
| mdprc 039 02 12 000 | Varian Medical Systems | ARIA Radiation Oncology | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106598 |
| mdprc 038 02 12 000 | Nemschoff Chairs, Inc. | Nemschoff Perinatal Bassinet | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106002 |
| mdprc 037 02 12 000 | Healthway Home Products, Inc | Air Purifier device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106910 |
| mdprc 036 02 12 000 | Alphatec Spine Inc | Implants, Solanas Posterior Stabilization System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104000 |
| mdprc 035 02 12 000 | Varian Medical Systems | Radiotherapy Systems, 4D Integrated Treatment Console (4DITC) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106587 |
| mdprc 034 02 12 000 | Stryker Howmedica Osteonics Corp | Implants, MEDPOR TITAN Cranial Temporal | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106899 |
| mdprc 033 02 12 000 | Ortho-Clinical Diagnostics | Laboratory, VITROS Chemistry Products DT Calibrator Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106492 |
| mdprc 032 02 12 000 | Novomedicus Llc | Prothesis, The Artificial Bur Prothesis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106735 |
| mdprc 031 02 12 000 | Kerr Corp | Dental cement, Maxcem Elite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106203 |
| mdprc 030 02 12 000 | Adenna Inc | Phantom black latex powder-free gloves | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106728 |
| mdprc 017 02 12 000 | Zimmer inc | Implants, non-sterile, Most Option Stem Distractor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105072 |
| mdprc 016 02 12 000 | Walgreen Company | Walgreens Quick Read, Digital Thermometer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105927 |
| mdprc 015 02 12 000 | Stryker Instruments | Sterile ,single use, disposable , Stryker PCD Precision System, Needle with Spineplex | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105884 |
| mdprc 014 02 12 000 | Ortho-Clinical Diagnostics | Laboratory, enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106733 |
| mdprc 013 02 12 000 | Mani Inc | MANI Needle and Suture Pack PGA Absorbable | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105997 |
| mdprc 012 02 12 000 | Lin-Zhi International Inc | IVD, Multi-Analyte Urine DAU Cutoff Calibrator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106374 |
| mdprc 011 02 12 000 | Gunnell, Inc. | Patient transfer, wheelchairs. Gas cylinders used in Gunnell manual wheelchairs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105241 |
| mdprc 010 02 12 000 | Cincinnati Sub-Zero Products Inc | Probes, Thermometer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105007 |
| mdprc 009 02 12 000 | Church & Dwight Inc | Dental, Toothbrush. Spinbrush Pro | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106647 |
| mdprc 008 02 12 000 | CareFusion | Central programming, monitoring, Alaris PC unit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106751 |
| mdprc 007 02 12 000 | AngioDynamics | Catheterization Kits, Various Morpheous CT Peripherally Inserted Central Catheter Tray Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106914 |
| mdprc 124 01 12 000 | Zimmer inc | Implants, knee prosthesis, Natural-Knee II Durasul All-Poly Patella | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106657 |
| mdprc 123 01 12 000 | Terumo Cardiovascular Systems Corporation | CDI Blood Parameter Monitoring System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105576 |
| mdprc 122 01 12 000 | Terumo Cardiovascular Systems Corporation | Vascular, The Terumo Advanced Perfusion System 1 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105471 |
| mdprc 121 01 12 000 | Lin-Zhi International Inc | Reagent, Barbiturate Enzyme Immunoassay | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106392 |
| mdprc 120 01 12 000 | Encore Medical, Lp | Prostheses, Joint, Foundation Hip System Series 460 Hip Stem Prostheses | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103532 |
| mdprc 119 01 12 000 | Biomet Inc | Implant, Surgery, SternaLock Blu Implant Tray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106198 |
| mdprc 118 01 12 000 | Surgical Appliance Industries | Help relieve tired, Truform Therapeutic Classic Medical Style Compression Pantyhose and Stockings | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105382 |
| mdprc 117 01 12 000 | SIEMENS | Picture Archiving and Communication Systems, Syngo plaza | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106410 |
| mdprc 116 01 12 000 | PENTAX Europe GmbH | Optical, monitors. Pentax Video Visualization devices. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106476 |
| mdprc 115 01 12 000 | Lin-Zhi International Inc | IVD, Multi-Analyte Urine DAU Control | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106237 |
| mdprc 114 01 12 000 | Gulf Medical Fiber optics Inc. | Lights, Surgical Headlight | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100769 |
| mdprc 113 01 12 000 | GE Healthcare | Scanning Systems, LOGIQ P6 Diagnostic Ultrasound Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106458 |
| mdprc 112 01 12 000 | Fresenius Medical Care | Optiflux Hemodialyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106328 |
| mdprc 111 01 12 000 | Codman & Shurtleff Inc | Neurosurgical procedures, Codman Cranial Access Kit and Disposable Intracranial Pressure (ICP) Kit, with Xylocaine | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105156 |
| mdprc 110 01 12 000 | Biomet Microfixation | Standard Offset Mandible in the Total Temporomandibular Joint (TMJ) Replacement System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106771 |
| mdprc 106 01 12 000 | Sechrist Industries Inc | Sechrist Hyperbaric Chamber Gurney. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105498 |
| mdprc 105 01 12 000 | Salter Labs | Bubble humidifier | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104930 |
| mdprc 104 01 12 000 | Navilyst Medical | NAMIC Convienience Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106322 |
| mdprc 103 01 12 000 | Hospira Inc | Hospira Blood Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106687 |
| mdprc 102 01 12 000 | Cypress Medical Products | Examination Gloves, Zee Clear Vinyl Medical | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105791 |
| mdprc 101 01 12 000 | Covidien | Disposable Syringe Fill Tubes, Handi-Fil | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106734 |
| mdprc 100 01 12 000 | CareFusion | Electroencephalographs, Microelectrode Amplifiers, Stimulators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104816 |
| mdprc 099 01 12 000 | Allen Medical Systems | Support a patient's head, Allen C-Flex Head Positioner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105422 |
| mdprc 098 01 12 000 | AGFA Corp | Image Digitization Systems, DX-G Computed Radiography Digitizer Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106055 |
| mdprc 087 01 12 000 | Teleflex Medical | DermaHood Neuro Elastic Retractors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105993 |
| mdprc 086 01 12 000 | Philips Healthcare | Multi Diagnost Eleva | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105784 |
| mdprc 085 01 12 000 | Medtronic Inc | Spinal System, MULTI-AXIAL SCREW | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105828 |
| mdprc 084 01 12 000 | Medical Compression Systems | Preventing deep Vein Thrombosis, ActiveCare DVT Medical Compression Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103789 |
| mdprc 083 01 12 000 | Synthes Inc | Bone Matrix Implants,Norian Skeletal Repair Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104316 |
| mdprc 082 01 12 000 | Eyezone | NeuLook COLOR CONTACT LENSES | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106091 |
| mdprc 081 01 12 000 | Baxter Healthcare | Baxter Interlink System , General-Purpose. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105971 |
| mdprc 065 01 12 000 | Varian Medical Systems | Portal Vision (Electronic Portal Image Device) R-Arm with 4D Integrated Treatment Console | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106201 |
| mdprc 064 01 12 000 | The Raymond Corporation | Raymond Laser alignment guide | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105699 |
| mdprc 063 01 12 000 | Teco Diagnostics | Urine Reagent Strips (URS) 10 Parameters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105523 |
| mdprc 062 01 12 000 | OrthoHelix Surgical Design Inc | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105467 |
| mdprc 061 01 12 000 | Navilyst Medical | Exodus Standard Loop Biliary Drainage Catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106448 |
| mdprc 060 01 12 000 | Osteotech Inc | Foil Pouch, Tyvek pouch Fracture repair, Grafton DBM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104904 |
| mdprc 059 01 12 000 | Ormco Corp | Orthodontic, TMA Archwires | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105877 |
| mdprc 058 01 12 000 | ICU Medical, Inc | IV Start Kits, Orbit and Orbit Micro, alcohol prep pads | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105695 |
| mdprc 048 01 12 000 | Philips Healthcare | Ventilators, Respironics Trilogy 100, 200 and 202 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104431 |
| mdprc 047 01 12 000 | Innovatech Medical Resources | Rotator cuff repair, bone anchor, suture cartridge, ablation wand Intended, arthroscopic and orthopedic procedures | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104345 |
| mdprc 046 01 12 000 | IKARIA Inc | INOmax DS (Delivery System), delivers INOMAX (nitric oxide for inhalation) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104896 |
| mdprc 045 01 12 000 | SIEMENS | Syngo Imaging XS Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105378 |
| mdprc 044 01 12 000 | Salter Labs | ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106145 |
| mdprc 043 01 12 000 | Oculus Innovative Sciences Inc | Puracyn OTC Wound & Skin Care Solution, Microcyn Dermatology and HydroGel Spray | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105228 |
| mdprc 042 01 12 000 | Endotec Inc | Beuchal Pappas Mobile Bearing Knee System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104503 |
| mdprc 041 01 12 000 | Ortho Development Corp | Escalade Acetabular Cup System, U-Joint Hex Head Driver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106309 |
| mdprc 040 01 12 000 | Integra LifeSciences Corporation | Catheters, Ventricular. Cranial Access Kits with Xylocaine | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106499 |
| mdprc 039 01 12 000 | Impact Instrumentation, Inc | MRI Reusable/Disposable Circuit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106429 |
| mdprc 038 01 12 000 | ConMed Linvatec Corporation | R2 Adult Zoll Non-Radiolucent Multifunction Electrodes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106249 |
| mdprc 037 01 12 000 | AngioDynamics | Hemodialysis and Apheresis, Catheter Set, DuraMax® | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106537 |
| mdprc 036 01 12 000 | Varian Medical Systems | Radiotherapy treatments, Varian brand Eclipse, Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106612 |
| mdprc 035 01 12 000 | Space labs Healthcare Inc | Cardio Express SL6 ECG cable | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106510 |
| mdprc 034 01 12 000 | LINET | Linet Remote Handset, bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106652 |
| mdprc 033 01 12 000 | Care Fusion | Medical Device Data System, NicVue Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106489 |
| mdprc 032 01 12 000 | Baxter Healthcare | Infusion Pump, Colleague CX and 3 Volumetric, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105691 |
| mdprc 031 01 12 000 | Advanced Sterilization Products | Hydrogen Peroxide Gas Plasma Sterilizer, STERRAD® 200 Sterilizer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106716 |
| mdprc 022 12 11 000 | Zimmer inc | ZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis | FDA |
| mdprc 021 12 11 000 | Varian Medical Systems | Radioterapy, accelerator, Head Ring Posts; of the Optical Guidance Platform and Floorstand devices | FDA |
| mdprc 020 12 11 000 | Varian Medical Systems | Radiation therapy, Varian brand GammaMed 12i Accessory | FDA |
| mdprc 019 12 11 000 | Varian Medical Systems | Radiotherapy, TrueBeam and TrueBeam STx | FDA |
| mdprc 018 12 11 000 | Synthes Inc | Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive | FDA |
| mdprc 017 12 11 000 | SCC Soft Computer | Software, SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. | FDA |
| mdprc 016 12 11 000 | RaySearch Laboratories AB | Radiationtherapy, RayStation | FDA |
| mdprc 015 12 11 000 | Radiometer America Inc | Monitor, Non-invasive, transcutaneous pCO2 electrodes | FDA |
| mdprc 014 12 11 000 | Nanotherapeutics, Inc | Origen DBM with Bioactive Glass | FDA |
| mdprc 013 12 11 000 | MAQUET Inc | Ventilator, Servo-I & Servo-S ventilator system | FDA |
| mdprc 012 12 11 000 | Elekta Inc | Radioterapy, XVI R4.5 X-ray Volume Imaging System | FDA |
| mdprc 011 12 11 000 | Boston Scientific Cardiac Rhythm Management Group | Pulse generator, defibrillator, Programmer, LATITUDE® Patient Management System | FDA |
| mdprc 010 12 11 000 | Bard Pcripheral Vascular (BPV) | The EnCor® biopsy probe, designed for use with EnCor® and EnCor® Enspire Vacuum Assisted Biopsy (VAB) driver systems. | FDA |
| mdprc 009 12 11 000 | Acute Innovations Llc | Screw, RibLoc Rib Fracture Plating System, Standard Screw | FDA |
| mdprc 008 12 11 000 | Toshiba Corp Medical Systems Co Ltd | Radiation, Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. | FDA |
| mdprc 007 12 11 000 | Philips Healthcare | Digital, a radiographic system, Philips Digital Diagnost Rel 3 | FDA |
| mdprc 006 12 11 000 | Elekta Inc | Radiotherapy, Stereotactic Circular Collimator | FDA |
| mdprc 005 12 11 000 | Atom Medical Corp | Incubator, Rabee Incu i | FDA |
| mdprc 004 12 11 000 | Arrow International Inc | Arrow International StimuCath(R) Continuous Nerve Block Kit | FDA |
| mdprc 121 11 11 000 | Terumo Cardiovascular Systems Corporation | Perfusion, Sarns Modular Perfusion System 8000, Circuit Board for MBattery Module | FDA |
| mdprc 120 11 11 000 | Terumo Cardiovascular Systems Corporation | Perfusion, Advanced Perfusion System 1 | FDA |
| mdprc 119 11 11 000 | Acrymed Incorporated | Dressing, ON-Q Silver Dressing | FDA |
| mdprc 118 11 11 000 | Philips Healthcare | Radiation, Magnetic Resonance Systems, Ingenia 1.5T and 3.0T MRI Systems. | FDA |
| mdprc 117 11 11 000 | Pelstar, Llc | Digital patient weighing scale, Health o Meter Professional Remote Display Digital Physician Scale | FDA |
| mdprc 116 11 11 000 | Microgenics Corp | Calibrators, Multigent Vancomycin Calibrators | FDA |
| mdprc 101 11 11 000 | SIEMENS | Radiation, (Single-Photon Emission Computed Tomography and Computed Tomography) System, Symbia T & S Series SPECT-CT System | FDA |
| mdprc 100 11 11 000 | SCC Soft Computer | software, laboratory, Softlab | FDA |
| mdprc 099 11 11 000 | SCC Soft Computer | software, laboratory, SoftLab GUI | FDA |
| mdprc 098 11 11 000 | International Biophysics Corp | Blood, open heart procedures, suction, IBC Suction Wand | FDA |
| mdprc 097 11 11 000 | Immunetech Inc | Non-sterile alcohol prep pads, MyAllergyTest, Specimen Collection Kit | FDA |
| mdprc 096 11 11 000 | Hospira Inc | Administer fluids, Hospira LifeShield Latex-Free 150 mL Burette SetB. | FDA |
| mdprc 095 11 11 000 | AGFA Corp. | Software used to IMPAX CardioVascular (CV) Admin Tool, AdminTool2 | FDA |
| mdprc 088 11 11 000 | GE Healthcare | Needle, radiotherapy, RAPID Strand Rx kit | Source FDA |
| mdprc 087 11 11 000 | Uplift Technologies Inc. | Chair, Lifting commode chair, Uplift Commode Assist | FDA |
| mdprc 086 11 11 000 | Stryker Endoscopy | Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device | FDA |
| mdprc 085 11 11 000 | Philips Medical Systems | Radiation, Gamma Camera ,SKYLight Gamma Camera System | FDA |
| mdprc 084 11 11 000 | Boston Scientific Cardiovascular Group | Vasculature, Introducer Sheaths, Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths | FDA |
| mdprc 083 11 11 000 | SCC Soft Computer | Software, SoftLab | FDA |
| mdprc 082 11 11 000 | C P Medical | Synthetic Absorbable Suture, Mono-Dox Synthetic Absorbable Suture | FDA |
| mdprc 081 11 11 000 | AGFA Corp. | Software, Reporting Module, IMPAX Cardiovascular Results Management (RM) | FDA |
| mdprc 080 11 11 000 | Cyberonics Inc | Stimulators, VNS Therapy Aspire HC Generator and VNS | FDA |
| mdprc 079 11 11 000 | AGFA Corp. | Echo Measurement Import via Optical Character Recognition (OCR), IMPAX CV | FDA |
| mdprc 078 11 11 000 | SCC Soft Computer | Software, SoftPath GUI | FDA |
| mdprc 077 11 11 000 | Meridian Bioscience Inc | Premier Enterohemorrhagic test kit (EHEC), Reagent Kits | FDA |
| mdprc 076 11 11 000 | Lifewatch Services Inc | Cardiac, sensor, Ambulatory Cardiac Telemetry, LifeStar ACT III Platinum Sensor, LifeStar ACT I Sensor, ACT Cellular Phone Monitor | FDA |
| mdprc 075 11 11 000 | Medtronic MiniMed | Infusion system, infusion pump, paradigm mio Infusion Sets | FDA |
| mdprc 074 11 11 000 | Cordis Corporation | Radiation, Angiographic, catheter, SUPER TORQUE MB Angiographic Catheter | FDA |
| mdprc 073 11 11 000 | Physio Control Inc | Defibrillator, LIFEPAK 20 | FDA |
| mdprc 072 11 11 000 | Stryker Orthopaedics | Prostheses, Restoration ADM | FDA |
| mdprc 071 11 11 000 | Alere San Diego | Prep Pads, PDI Alcohol Prep Pads packaged in the INRatio kit | FDA |
| mdprc 070 11 11 000 | Pentron Clinical Technologies LLC | Adhesive Resin Cement | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104859 |
| mdprc 069 11 11 000 | Invacare Corporation | Beds, Invacare bariatric bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102837 |
| mdprc 068 11 11 000 | Greiner Bio-One Inc | Tube, Blood collection, Vacuette tube, Vacuette 4ml EDTA DK2 tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103999 |
| mdprc 067 11 11 000 | Albahealth LLC | Anti-Embolism Wrap System, Pulstar(R) DVT PREVENTION SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104473 |
| mdprc 055 11 11 000 | Philips Medical Systems | Extended Brilliance Workstation-NM (EBW-NM) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104283 |
| mdprc 054 11 11 000 | King International | Shoulder Flex Massage Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103827 |
| mdprc 053 11 11 000 | Greiner Bio-One Inc | VACUETTE Blood Collection, Quick Shield with Snappy Safety Holder | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103997 |
| mdprc 052 11 11 000 | Capintec Inc | Capintec CRC 25 PET, dose calibrator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102757 |
| mdprc 046 11 11 000 | Synthes Inc | Spine T-PAL Spacer System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104221 |
| mdprc 045 11 11 000 | Medtronic Inc Cardiac Rhythm Disease Management Div | CryoCath Arctic Front CryoAblation Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104277 |
| mdprc 044 11 11 000 | Medrad Inc | Stellant Sterile Disposable Syringe Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104852 |
| mdprc 043 11 11 000 | Biopro, Inc | Orthopedic femoral head | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104523 |
| mdprc 042 11 11 000 | Becton Dickinson & Co. (BD) | Blister packaged insulin syringe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104880 |
| mdprc 041 11 11 000 | AMO Manufacturing USA, LLC | IntraLase Femtosecond Laser System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104854 |
| mdprc 025 11 11 000 | Terumo Cardiovascular Systems Corporation | CDI 500 Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103146 |
| mdprc 024 11 11 000 | Picis Inc | Picis Anesthesia Manager | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104224 |
| mdprc 023 11 11 000 | Merz Aesthetics, Inc | Injectable Implant, Radiesse® Volume | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104304 |
| mdprc 022 11 11 000 | MAKO Surgical Corp | RIO Robot Arm Interactive Orthopedic System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98566 |
| mdprc 021 11 11 000 | Davol, Inc | Bard® Ventralex" ST Medium Circle with Strap Hernia Patch | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104352 |
| mdprc 020 11 11 000 | Bioplate Inc | Bioplate Titanium Fixation System, Sterile Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=91084 |
| mdprc 088 10 11 000 | Sierra Scientific Instruments Inc | Visualization System (MVS), AR ManoShield | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104678 |
| mdprc 087 10 11 000 | Salter Labs | Mask adult, oxygen | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99388 |
| mdprc 086 10 11 000 | Mizuho OSI | Modular Orthopedic Surgical Table Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103036 |
| mdprc 085 10 11 000 | Lifeline First Aid LLC | Mountain, ARC DISASTER, Base Camp, Highlands, Wilderness, First Aid Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104291 |
| mdprc 084 10 11 000 | GE Healthcare | Magnetic Resonance Imaging, MSK Extreme 1.5T Scanning Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103010 |
| mdprc 083 10 11 000 | GE Healthcare | Radiographic Systems, Digital, Senographe DS Full and Senographe Essential Mammography Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102282 |
| mdprc 082 10 11 000 | CareFusion | Portable critical care, EnVe Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104017 |
| mdprc 081 10 11 000 | Beckman Coulter Inc | Biological fluid, SYNCHRON | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101427 |
| mdprc 080 10 11 000 | Baxter Healthcare | Baxter Flo-Gard 6301 Volumetric, Infusion Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104641 |
| mdprc 079 10 11 000 | Corpak MedSystems | CORFLO 300 Enteral Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104131 |
| mdprc 078 10 11 000 | Carl Zeiss Meditec Inc | OPMI VARIO 700, Surgical Microscope | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104239 |
| mdprc 064 10 11 000 | The Anspach Effort, Inc. | Sterile Bone Cutting Burrs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104176 |
| mdprc 063 10 11 000 | Siemens Healthcare Diagnostics GmbH | Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103939 |
| mdprc 062 10 11 000 | Medtronic Perfusion Systems | Medtronic Disposable Pressure Display Set and Box | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104227 |
| mdprc 061 10 11 000 | Biomet Inc | MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103982 |
| mdprc 058 10 11 000 | Wright Medical Technology Inc | Anchor Lok, Soft Tissue Anchor System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104210 |
| mdprc 050 10 11 000 | Terumo Cardiovascular Systems Corporation | Tubing, Suction , Sarns Intracardiac, Sarns Rigid Intracardiac Suckers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103985 |
| mdprc 044 10 11 000 | Worldwide Medical Technologies | Prostate Seeding Needle, Applicator Technique | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103394 |
| mdprc 043 10 11 000 | Siemens Healthcare Diagnostics | Dimension(R) EXL LOCI Cardiac Troponin I Calibrator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103938 |
| mdprc 042 10 11 000 | Richard-Allan Scientific | Rotary Microtome, Thermo Scientific Microm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102246 |
| mdprc 041 10 11 000 | Interventional Spine Inc | BONE-LOK PLS System, PERPOS Driver and PERPOS PLS System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99402 |
| mdprc 040 10 11 000 | Edan Instruments Inc | SE-1, SE-3 and SE-601 series, ECG Cable | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103882 |
| mdprc 039 10 11 000 | Cooper Vision | Soft Contact Lenses, AVAIRA Toric | Z-0044-2012 |
| mdprc 026 10 11 000 | Accuray Inc | Radiation Therapy, CyberKnife Robotic Radiosurgery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104019 |
| mdprc 011 10 11 000 | Siemens Healthcare Diagnostics | Vitro diagnostic , Dimension Vista® Cuvettes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103543 |
| mdprc 010 10 11 000 | Philips Healthcare | Radiology, MDC Picture and Archiving Communication Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103870 |
| mdprc 009 10 11 000 | Biomet Microfixation | Latex Free Rubber Band | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104047 |
| mdprc 005 10 11 000 | Cyberonics Inc | VNS Therapy Demipulse Duo Generator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101368 |
| mdprc 004 10 11 000 | Medtronic Navigation Inc | Right and Left Long Tactile Probe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97591 |
| mdprc 003 10 11 000 | B Braun Medical Inc | Outlook ES Safety Infusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103856 |
| mdprc 002 10 11 000 | Respironics Novametrix | Philips, non-invasive monitoring | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102224 |
| mdprc 001 10 11 000 | Hospira Inc | Infusion Pumps, Plum A+,A+3 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104074 |
| mdprc 073 09 11 000 | Invacare Corporation | Walkers, wheeled adult and junior walkers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99590 |
| mdprc 072 09 11 000 | GE Healthcare | Radiation, Software, ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103023 |
| mdprc 069 09 11 000 | Picis Inc | Software, CareSuite | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86830 |
| mdprc 068 09 11 000 | Baxter Healthcare | Logix Order Entry (OE) Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103498 |
| mdprc 067 09 11 000 | AngioDynamics Inc | Surgical ,Nanoknife | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103817 |
| mdprc 059 09 11 000 | Cardiac Science Corporation | Powerheart automated external defibrillator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102214 |
| mdprc 058 09 11 000 | AngioDynamics Inc | UNI*FUSE, INFUSION SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103807 |
| mdprc 054 09 11 000 | Varian Medical Systems | Treatment Console, 4D Integrated | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103151 |
| mdprc 053 09 11 000 | Terumo Cardiovascular Systems Corporation | Cardioplegia Monitors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103024 |
| mdprc 052 09 11 000 | Pride Mobility Products Ltd | Mobility medical device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103748 |
| mdprc 051 09 11 000 | Philips Healthcare | Radiological Image Processing System , PCR Eleva | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102849 |
| mdprc 050 09 11 000 | Philips Healthcare | Brilliance Computed Tomography Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103270 |
| mdprc 049 09 11 000 | Becton Dickinson & Co. (BD) | DNA. RNA,GBS, BD MAX System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103132 |
| mdprc 048 09 11 000 | AngioDynamics | Angiographic Catheter, Soft-Vu | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103751 |
| mdprc 046 09 11 000 | The Anspach Effort, Inc. | Single Use, Sterile, Bone Cutting Burrs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101551 |
| mdprc 045 09 11 000 | Philips Medical Systems | Diagnostic Imaging Systems, Philips GEMINI | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101505 |
| mdprc 044 09 11 000 | Hamamatsu Corporation | X-ray system, Micro Focus X-Ray generator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103604 |
| mdprc 035 09 11 000 | TiSport | TiLite ZR Series 2 and ZRA Series 2, Wheelchairs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102216 |
| mdprc 034 09 11 000 | Terumo Cardiovascular Systems Corporation | Level Detect II Mount Pads | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102829 |
| mdprc 033 09 11 000 | Orthofix | Ratcheting Torque Limiting Handles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99424 |
| mdprc 032 09 11 000 | Covidien | Loading Units, DUET TRS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103762 |
| mdprc 031 09 11 000 | C P Medical | Non-Absorbable Suture, Monomid | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103603 |
| mdprc 021 09 11 000 | Varian Medical Systems | Trilogy Mx, On-Board Imager (OBI) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102071 |
| mdprc 020 09 11 000 | Varian Medical Systems | Varian Treatment | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103135 |
| mdprc 019 09 11 000 | Steris Corp | Liquid Chemical Sterilant Processing Systems, System 1E | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103574 |
| mdprc 018 09 11 000 | Steris Corp | Washer/Disinfectors, Reliance Vision and Single Chamber | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103262 |
| mdprc 016 09 11 000 | Accuray Inc | Hi-Art System, TomoTherapy | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102795 |
| mdprc 087 08 11 000 | Encision Inc | Suction Irrigation Electrodes, Encision AEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103728 |
| mdprc 086 08 11 000 | Covidien Ltd | Generator, Coagulation, Evident MWA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103590 |
| mdprc 085 08 11 000 | Varian Medical Systems | Radiation Therapy, 4D Integrated Treatment Console (4DITC) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102343 |
| mdprc 084 08 11 000 | Applied Medical Resources | Optical Access System, trocars, Kii | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103070 |
| mdprc 083 08 11 000 | Arjo Huntleigh | Assistive Equipments, Entroy Pool Lift | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103152 |
| mdprc 082 08 11 000 | GE Medical Systems | DASH Patient Monitors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99459 |
| mdprc 080 08 11 000 | Sysmex America Inc | Automated Hematology Analyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103015 |
| mdprc 073 08 11 000 | Alliant Enterprises LLC | Adjustable Vent Valve, TruChoice and 3-T Medical systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103026 |
| mdprc 071 08 11 000 | Varian Medical Systems. | High-Definition 120 Multileaf Collimator. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101854 |
| mdprc 070 08 11 000 | Steris Corp | Indicator Strips and Challenge Pack, Verify® SixCess | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103396 |
| mdprc 069 08 11 000 | Draeger Medical Inc | Portable Patient Monitor, Infinity Gamma X XL and Delta. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103117 |
| mdprc 068 08 11 000 | Bio-Rad Laboratories Inc | Enzyme, Reagents, Kallestad Mouse Stomach/Kidney (MSK) Test Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93068 |
| mdprc 063 08 11 000 | Mckesson Information Solutions LLC | Horizon Medical Imaging | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102413 |
| mdprc 062 08 11 000 | Steris Corp | Low Temperature Sterilization Systems, Amsco V-PRO 1 and Amsco V-PRO 1 Plus | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102995 |
| mdprc 061 08 11 000 | Spacelabs Healthcare Inc | Portable patient monitor with arrhythmia detection or alarms | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94553 |
| mdprc 059 08 11 000 | Siemens Healthcare Diagnostics | IVDs, Dimension Calcium Flex Reagent | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102582 |
| mdprc 045 08 11 000 | Varian Medical Systems | Eclipse Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102598 |
| mdprc 044 08 11 000 | Beckman Coulter Inc | Access Immunoassay Systems, Unconjugated Estriol | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101912 |
| mdprc 043 08 11 000 | SIEMENS | Linear Accelerator, ARTISTE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101290 |
| mdprc 042 08 11 000 | Elekta/IMPAC | LANTIS Oncology Information Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102338 |
| mdprc 041 08 11 000 | Varian Medical Systems | Clinac, Trilogy Tx and Novalis Tx Linear Accelerators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101078 |
| mdprc 040 08 11 000 | Varian Medical Systems | Needles, Plastic Needles with Mandrin Guides | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102637 |
| mdprc 039 08 11 000 | Varian Medical Systems | Titanium Intrauterine Probes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102647 |
| mdprc 038 08 11 000 | Varian Medical Systems | Flexible Applicator Probes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102571 |
| mdprc 037 08 11 000 | Teledyne Instruments | Micro-Fuel Cell Oxygen Sensor, Class RI5 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98984 |
| mdprc 036 08 11 000 | Applied Medical Resources | Surgical Clamp Inserts | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102721 |
| mdprc 035 08 11 000 | Hologic Inc | Fluoroscan Mini C-arm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102624 |
| mdprc 034 08 11 000 | Stryker Medical | EMS Stair - Pro Evacuation and Evacuation Stryker Chairs. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101240 |
| mdprc 033 08 11 000 | GE Healthcare | Seno Advantage Workstations | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100969 |
| mdprc 032 08 11 000 | Animas Corporation | Animas Insulin Infusion Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102988 |
| mdprc 031 08 11 000 | Sunrise Medical | DeVilbiss Heated Humidifier | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100885 |
| mdprc 030 08 11 000 | Siemens Medical Solutions | Radiation Therapy Pallet | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100609 |
| mdprc 020 08 11 000 | Teleflex Medical | Catheters, Rusch Female | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102359 |
| mdprc 019 08 11 000 | Boston Scientific Corporation | Pinnacle Pelvic Floor Repair Kit (Anterior), Apical and Pinnacle Pelvic Floor Repair Kit (Posterior) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100416 |
| mdprc 018 08 11 000 | Welch Allyn Protocol Inc | Wireless Network Access Points, Aruba Model 65 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100762 |
| mdprc 017 08 11 000 | Cardiac Science Corporation | Defibrillator, Powerheart AED, G2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102212 |
| mdprc 016 08 11 000 | Spectranetics Corporation | Laser Guide Catheter, Spectranetics Turbo-Booster Laser Guide Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102450 |
| mdprc 015 08 11 000 | Philips Medical Systems | BrightView XCT and X Gamma Camera | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102054 |
| mdprc 014 08 11 000 | Haemonetics Corp | Cardiovascular Perioperative Autotransfusion System, Haemonetics cardioPAT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102445 |
| mdprc 013 08 11 000 | Biomet Inc | Prosthesis | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100968 |
| mdprc 004 08 11 000 | Spacelabs Healthcare Inc | Vital Sign elance Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102807 |
| mdprc 003 08 11 000 | Philips Healthcare | Computer tomography system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101749 |
| mdprc 002 08 11 000 | Biomet Microfixation | SYSTEM SCREWDRIVER BLADE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100613 |
| mdprc 112 07 11 000 | Salient Surgical Technologies Inc | Electrosurgical Units | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102436 |
| mdprc 111 07 11 000 | I-Flow | Infusion Pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101372 |
| mdprc 110 07 11 000 | Vital Signs Inc A GE Healthcare Co | Vital Signs Passive Humidification Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100921 |
| mdprc 109 07 11 000 | Toshiba Corp Medical Systems Co Ltd | Aplio Ultrasound Diagnostic System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97589 |
| mdprc 108 07 11 000 | Global Focus Marketing & Develop | Silencer Centrifuges | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102133 |
| mdprc 107 07 11 000 | Varian Medical Systems | Radiation Therapy, Varian Clinac Linear Accelerators | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101083 |
| mdprc 106 07 11 000 | Cincinnati Sub-Zero Products Inc | Warming Device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100848 |
| mdprc 093 07 11 000 | Beckman Coulter Inc | IVD, Radioimmunoassay, Reagents, DHEA RIA Reagent | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97871 |
| mdprc 092 07 11 000 | MADRImed | Saws, Surgical, Reciprocating Saw Attachments | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101341 |
| mdprc 091 07 11 000 | Stryker Medical | Stretchers, Stryker Medical Stretchers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102120 |
| mdprc 090 07 11 000 | Medrad Inc | Fluid Management Injection System, MEDRAD Avanta | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101479 |
| mdprc 089 07 11 000 | Philips Medical Systems | Gamma Camera System, Philips brand Bright View. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101026 |
| mdprc 088 07 11 000 | Biomet Microfixation | Internal Fixation Screws, THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100808 |
| mdprc 087 07 11 000 | Covidien | Radiation, Angiographic or CT, Syringes, Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101150 |
| mdprc 076 07 11 000 | Biomet Microfixation | Arthroscopy, Procedure and Arthrosimplicity Kits, TMJ SYSTEM On Point SCOPE PROCEDURE KIT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102093 |
| mdprc 067 07 11 000 | Covidien | No absorbable Sutures,(SOFSILK, SURGILON, and TI•CRON ) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101183 |
| mdprc 066 07 11 000 | Boston Scientific Corporation | Various Tracheo bronchial Endoprosthesis Stents | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101124 |
| mdprc 065 07 11 000 | Sysmex America Inc | Hematology, Automated Analyzers, lytic reagent, Sysmex Stromatolyser-IM (SIM-220A) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100607 |
| mdprc 064 07 11 000 | Lifescan Johnson & Johnson | OneTouch Delica Lancing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101053 |
| mdprc 063 07 11 000 | Dental Equipment LLC | Dental, Dental Light, LuxStar | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101128 |
| mdprc 062 07 11 000 | Cincinnati Sub-Zero Products Inc | Convective Warming Devices, WarmAir | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100840 |
| mdprc 061 07 11 000 | Baxter Healthcare | Catheter, Catheter Extension, Baxter Interlink System Non-DEHP I.V. Catheter Extension Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102086 |
| mdprc 050 07 11 000 | Vitrolife, Inc. | Perfusion, Perfadex with THAM, XVIVO Perfusion AB | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100378 |
| mdprc 049 07 11 000 | Teleflex Medical | Humidifier Adapters,(Hudson RCI) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100876 |
| mdprc 048 07 11 000 | Varian Medical Systems | Radiotherapy, Linear Accelerators, Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100743 |
| mdprc 047 07 11 000 | Varian Medical Systems | Radiotherapy, Treatment Planning System, Eclipse | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100818 |
| mdprc 046 07 11 000 | SIEMENS | Linear Accelerator systems, ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100961 |
| mdprc 045 07 11 000 | Medtronic Navigation Inc | PACS, StealthStation systems, DICOM Query/Retrieve, Sofrware Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88795 |
| mdprc 044 07 11 000 | Beckman Coulter Inc | Analyzers, Clinical Systems, Integrated Workstation, UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90200 |
| mdprc 043 07 11 000 | Bard Access Systems | Catheters, Cuffed central venous catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101247 |
| mdprc 042 07 11 000 | Ethicon Inc | Various Drain Products | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100045 |
| mdprc 041 07 11 000 | Philips Medical Systems | Imaging, PercuNav and Tool Connection Unit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100799 |
| mdprc 040 07 11 000 | Zimmer inc | Driver/Extractors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99671 |
| mdprc 039 07 11 000 | Terumo Cardiovascular Systems Corporation | Advanced Perfusion System 1 Bases | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99575 |
| mdprc 038 07 11 000 | Haemonetics Corp | Analyzer System, Thrombelastograph Hemostasis, TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100407 |
| mdprc 037 07 11 000 | DJO Surgical | Reverse Shoulder Prosthesis Socket Shells | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99595 |
| mdprc 036 07 11 000 | Cambridge Endoscopic Devices, Inc | Endoscopic, Scissors, Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100610 |
| mdprc 035 07 11 000 | BARRX Medical Inc | ULTRA Ablation Catheters(HALO90 ) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100503 |
| mdprc 034 07 11 000 | Kapp Surgical Instrument Inc | X-ray, Target Ring, Bariatric Target Ring (Nitinol) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100856 |
| mdprc 033 07 11 000 | AMS USA | Repair System, Elevate Anterior and Apical Prolapse Repair Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100412 |
| mdprc 032 07 11 000 | Varian Medical Systems | Radiotherapy, Linear Accelerators, Trilogy Mx or TrueBeam Radiotherapy Delivery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100785 |
| mdprc 031 07 11 000 | Varian Medical Systems | Radiosurgery, Linear Accelerator, Varian High Energy Linear Accelerator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100758 |
| mdprc 030 07 11 000 | Varian Medical Systems | Radiation, Oncology, Image Database, ARIA | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100749 |
| mdprc 029 07 11 000 | Beckman Coulter Inc | IVDs, Reagnet, Immunoassay, Active Cortisol Enzyme Immunoassay (EIA) kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90374 |
| mdprc 016 07 11 000 | St. Jude Medical Inc | Monitor, Diagnosis, Implantable Cardiac Monitor (ICM), SJM Confirm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99926 |
| mdprc 013 07 11 000 | SCC Soft Computer | Software, Soft Reports | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94634 |
| mdprc 012 07 11 000 | Ventana Medical Systems Inc | Reagents, iVIEW and ultraView Universal DAB Detection Kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100423 |
| mdprc 011 07 11 000 | Cincinnati Sub-Zero Products Inc | Warming/Cooling Units | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100747 |
| mdprc 010 07 11 000 | Varian Medical Systems | Radiation Treatment Planning System, Eclipse | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100394 |
| mdprc 009 07 11 000 | Staar Surgical Co. | Ophthalmic, Lens, STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100868 |
| mdprc 008 07 11 000 | Codman & Shurtleff Inc | ENTERPRISE Vascular Reconstruction Device and Delivery Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98486 |
| mdprc 007 07 11 000 | Teleflex Medical | CrystalClear Tracheostomy Tube Cuffed, Sterile Pack; | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99651 |
| mdprc 006 07 11 000 | Pall Life Sciences | Infusion pumps, Admixture Filter, Pall "TNA1" Total Nutrient Admixture Filter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101496 |
| mdprc 005 07 11 000 | ConMed Linvatec Corporation | Shoulder Restoration System, CrossFT Suture Anchor with Two 2 Hi-Fi Sutures | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100643 |
| mdprc 004 07 11 000 | Baxter Healthcare | Infusion Pumps, Baxter Solution Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100585 |
| mdprc 122 06 11 000 | VBM Medical Inc | Ventilation Catheters, 14 G Jet | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100370 |
| mdprc 121 06 11 000 | Terumo Cardiovascular Systems Corporation | CDI Blood Parameter Monitoring Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100193 |
| mdprc 120 06 11 000 | Medcomp | Titan Hemodialysis Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100757 |
| mdprc 112 06 11 000 | Biosense Webster Inc. | Various Electrode Catheters with Auto ID Technology | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100470 |
| mdprc 110 06 11 000 | Becton Dickinson & Co. (BD) | IVDs, System Software, BACTEC" FX Instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100454 |
| mdprc 109 06 11 000 | Siemens Medical Solutions | Camera imaging system, Linear accelerator systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100356 |
| mdprc 108 06 11 000 | Beckman Coulter Inc | Laboratory, Analyzers, Clinical Chemistry, Beckman Unicel DxC 600 and DxC 800 Clinical Systems, Mixer/Wash | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90458 |
| mdprc 107 06 11 000 | MAQUET Inc | Ventilator Systems, SERVO-i and SERVO-s | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100306 |
| mdprc 106 06 11 000 | BD Biosciences | ProbeTec Chlamydia trachomatis and Neisseria gonorrhoeae Amplification Control Reagent Packs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100457 |
| mdprc 105 06 11 000 | CMS Inc Div Elekta AB | Radiation Treatment Planning System, Interplant | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98759 |
| mdprc 104 06 11 000 | Arcadia Medical Corporation | Respiratory, Tracheostomy Tube, Silicone CTS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100382 |
| mdprc 103 06 11 000 | Vital Signs Inc A GE Healthcare Co | Pressure Infusors, Infusable and Infusa Scan | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99352 |
| mdprc 102 06 11 000 | Biomet Inc | Prosthesis, Discovery Elbow System with Humeral Condyle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100452 |
| mdprc 101 06 11 000 | Alere LTD | Alcohol Prep Pads, Triad | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100988 |
| mdprc 100 06 11 000 | Vital Signs Inc A GE Healthcare Co | Cuffable Blood Pressure Cuffs | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100421 |
| mdprc 099 06 11 000 | Terumo Cardiovascular Systems Corporation | Pressure Monitoring Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100579 |
| mdprc 098 06 11 000 | Stryker | Various Instrument Sterilization Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101010 |
| mdprc 097 06 11 000 | Spacelabs Healthcare Inc | Analyzer, Programmable Diagnostic Computer, Pathfinder Holter Analyzer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100815 |
| mdprc 096 06 11 000 | Integrated Orbital Implants Inc | Implant, Eye Sphere Wrap, Coated Bio-Eye Orbital Implant with Conformer. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100459 |
| mdprc 082 06 11 000 | Becton Dickinson & Co. (BD) | Laboratory, OXACILLIN SCREEN AGAR, BBL" | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100500 |
| mdprc 080 06 11 000 | Leica Microsystems Inc. | IVDs, Rapid Tissue Processor, Peloris II | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99479 |
| mdprc 079 06 11 000 | CMS Inc Div Elekta AB | Radiation Treatment Planning System, Focal | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98807 |
| mdprc 078 06 11 000 | CMS Inc Div Elekta AB | Radiation Treatment Planning System, XiO | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98844 |
| mdprc 077 06 11 000 | CMS Inc Div Elekta AB | Radiation Treatment Planning System, Focal | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98843 |
| mdprc 075 06 11 000 | CMS Inc Div Elekta AB | Radiation Treatment Planning System, Focal | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98822 |
| mdprc 074 06 11 000 | Roche Diagnostics Corp | COBAS AmpliPrep/COBAS TaqMan Hepatitis(Reagents) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100296 |
| mdprc 073 06 11 000 | Kinamed Inc | Plate System Driver, SuperCable ScrewDriver | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100337 |
| mdprc 072 06 11 000 | Integra LifeSciences Corporation | CUSA NXT Ultrasonic Tissue Ablation Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100406 |
| mdprc 071 06 11 000 | CMS Inc Div Elekta AB | Radiation Treatment Planning System, XiO | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97479 |
| mdprc 070 06 11 000 | Boston Scientific Corporation | Stent System, Innova Self-Expanding Stent System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100508 |
| mdprc 069 06 11 000 | Mettler Electronics Corp | Decompression System, Mettler Traction, MTD 4000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100298 |
| mdprc 068 06 11 000 | CMS Inc Div Elekta AB | Radiation Treatment Planning System, XiO | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98677 |
| mdprc 067 06 11 000 | CMS Inc Div Elekta AB | XiO RTP System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98664 |
| mdprc 066 06 11 000 | CMS Inc Div Elekta AB | XiO Radiation treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98665 |
| mdprc 065 06 11 000 | CMS Inc Div Elekta AB | Focal Radiation Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98778 |
| mdprc 064 06 11 000 | CMS Inc Div Elekta AB | XiO RTP System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98683 |
| mdprc 063 06 11 000 | CMS Inc Div Elekta AB | XiO Radiation Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98684 |
| mdprc 062 06 11 000 | CMS Inc Div Elekta AB | XiO RTP System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98753 |
| mdprc 061 06 11 000 | CMS Inc Div Elekta AB | Monaco Radiation Treatment Planning Workstation. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97545 |
| mdprc 059 06 11 000 | Opti Medical Systems Inc | OPTI LION E-Plus Cassette | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98847 |
| mdprc 058 06 11 000 | GE Healthcare | GE Centricity Laboratory Instrument Interface Data Innovations Instrument Manager Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99879 |
| mdprc 057 06 11 000 | Datascope Corp | Intra-Aortic Balloon Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99835 |
| mdprc 056 06 11 000 | CMS Inc Div Elekta AB | Monaco Radiation Treatment Planning Workstation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97342 |
| mdprc 055 06 11 000 | CMS Inc Div Elekta AB | Focal Radiation Treatment Planning Workstation | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97560 |
| mdprc 054 06 11 000 | CMS Inc Div Elekta AB | Focal Radiation Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98748 |
| mdprc 053 06 11 000 | CMS Inc Div Elekta AB | Monaco RTP System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98760 |
| mdprc 052 06 11 000 | CMS Inc Div Elekta AB | Monaco Radiation Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98825 |
| mdprc 037 06 11 000 | Biomet Inc | Porous Plasma Spray (PPS), Regenerex, Regenerex (TM) Ringloc Acetabular System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99961 |
| mdprc 036 06 11 000 | Biomet Inc | Prostheses, Comprehensive, Bio-modular, bi-angular Reverse Shoulder Humeral Trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99606 |
| mdprc 035 06 11 000 | Newport Medical Instruments Inc | Newport e360 Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99720 |
| mdprc 034 06 11 000 | Boston Scientific Corporation | Atlantis, iCross SR Pro 2, 40 MHz Coronary Imaging Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100636 |
| mdprc 033 06 11 000 | AGFA Corp | Cardio Review Station (CRS) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98834 |
| mdprc 014 06 11 000 | Newport Medical Instruments Inc | Newport HT70 Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99719 |
| mdprc 012 06 11 000 | Linet spol. s r.o. | Eleganza 3 Hospital Bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100295 |
| mdprc 010 06 11 000 | CMS Inc Div Elekta AB | XiO Radiation Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98670 |
| mdprc 008 06 11 000 | CMS Inc Div Elekta AB | XiO Radiation Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98841 |
| mdprc 006 06 11 000 | Capsule Tech Inc | Capsule Neuron UMPC | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99753 |
| mdprc 005 06 11 000 | Alere LTD | Cholestech Profile GLU Test Cassettes | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99591 |
| mdprc 001 06 11 000 | Encision Inc | AEM Disposable Scissors | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99521 |
| mdprc 098 05 11 000 | ZOLL Medical Corp | Zoll E Series BLS Defibrillator/Pacemaker/Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99664 |
| mdprc 097 05 11 000 | Wavelight AG | WaveLight Femtosecond Laser System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99665 |
| mdprc 096 05 11 000 | Nurse Assist, Inc | Various urological catheter trays | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98850 |
| mdprc 095 05 11 000 | Newport Medical Instruments Inc | Newport HT50 Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99738 |
| mdprc 094 05 11 000 | Newport Medical Instruments Inc | Newport HT50® Ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99708 |
| mdprc 093 05 11 000 | Medela Inc | TENPAO AC Adaptor, Transformer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99330 |
| mdprc 092 05 11 000 | Express Diagnostics Inc | DrugCheck | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99781 |
| mdprc 091 05 11 000 | Covidien | URI-DRAIN Male Urinary Control Device, URI-DRAIN Standard Male External Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99861 |
| mdprc 090 05 11 000 | Biomet Microfixation | 6 HOLE REGULAR DOUBLE (Y) PLATE | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98786 |
| mdprc 089 05 11 000 | Baxter Healthcare | LOGIX Order Entry (OE) Software, management | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99299 |
| mdprc 077 05 11 000 | bioMerieux Inc | BacT/ALERT - FA Reagent Bottle. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99580 |
| mdprc 076 05 11 000 | Stryker Medical | Impression Mattress | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99454 |
| mdprc 075 05 11 000 | Siemens Medical Solutions | ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99529 |
| mdprc 074 05 11 000 | Salter Labs | Adult Nasal Cannula | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99597 |
| mdprc 073 05 11 000 | Beckman Coulter Inc | SYNCHRON Systems Calibrator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99589 |
| mdprc 072 05 11 000 | Varian Medical Systems | High Energy Linear Accelerator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99592 |
| mdprc 071 05 11 000 | Beckman Coulter | COULTER® Ac"T" 5diff Fix Reagent. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99603 |
| mdprc 070 05 11 000 | Varian Medical Systems | Eclipse Treatment Planning System, Client software versions 8.0 through 8.6 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99625 |
| mdprc 069 05 11 000 | Siemens Medical Solutions | ARTISTE , ONCOR and PRIMUS accelerators. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99531 |
| mdprc 068 05 11 000 | Philips Healthcare | PAS-210 Remote Active Speakers Kit. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99864 |
| mdprc 067 05 11 000 | Beckman Coulter Inc | Access Immunoassay Systems, Thyroglobulin | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96293 |
| mdprc 066 05 11 000 | Baxter Healthcare | Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99634 |
| mdprc 051 05 11 000 | Siemens Medical Solutions | ARTISTE / RT Therapist v4.1 system. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99503 |
| mdprc 049 05 11 000 | Becton Dickinson & Co. (BD). | BD Nokor Admix Needle. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99380 |
| mdprc 048 05 11 000 | StatSpin, Inc. | Statspin Express 4 Centrifuge. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96248 |
| mdprc 047 05 11 000 | Digisonics Inc | Management system, DigiView software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99270 |
| mdprc 046 05 11 000 | Animas Corporation | Cartridge/Syringe Piston component of Insulin Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98100 |
| mdprc 032 05 11 000 | Philips Medical Systems | Gamma camera, Brightview XCT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98985 |
| mdprc 030 05 11 000 | SIEMENS | Radiology, Siemens ACUSON | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84543 |
| mdprc 029 05 11 000 | SIEMENS | ACUSON S2000 ABVS Ultrasound System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99480 |
| mdprc 028 05 11 000 | Biomet 3i Inc | Dental Implants, Osseotite Certain Implant(s) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98994 |
| mdprc 027 05 11 000 | Becton Dickinson & Co. (BD) | IVD, BACTEC MGIT AST system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99444 |
| mdprc 026 05 11 000 | Baxter Healthcare | Baxter Portable Elastomeric Infusion System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98608 |
| mdprc 025 05 11 000 | Allied Healthcare Products Inc | Carbon Dioxide Absorbent Granules, CarbO2Lime | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95245 |
| mdprc 016 05 11 000 | Biomet Inc | Low Profile Self-Tapping Bone Screw | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98992 |
| mdprc 014 05 11 000 | Beckman Coulter Inc | Coulter Cellular Analysis System, UniCel DxH 800 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98899 |
| mdprc 013 05 11 000 | Carl Zeiss Meditec Inc | Tomographic and biomicroscopic imaging device | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99272 |
| mdprc 010 05 11 000 | Varian Medical Systems | 4D Intergrated Treatment Console | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98761 |
| mdprc 009 05 11 000 | SIEMENS | ACUSON Antares System, ACUSON Sequoia System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84462 |
| mdprc 008 05 11 000 | Digisonics Inc | DOCTORS REVIEW SYSTEM | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99188 |
| mdprc 007 05 11 000 | Radiometer America Inc | Portable Blood Gas Analyzer System - ABL90 FLEX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98848 |
| mdprc 006 05 11 000 | Neuro Resource Group Inc | InterX Sport Devices | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98823 |
| mdprc 005 05 11 000 | DePuy International Limited | Confidence® Introducer Needle Side Hole, Confidence® Diamond Tip Introducer Needle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98846 |
| mdprc 004 05 11 000 | Bio-Rad Laboratories Inc | BioPlex 2200 EBV IgG Calibrator Set | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98905 |
| mdprc 003 05 11 000 | Biomet Inc | Biomet CC I-Beam Tibial Plate | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99023 |
| mdprc 063 04 11 000 | Advanced Instruments Inc | Multi-Sample Osmometer | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98087 |
| mdprc 062 04 11 000 | Beckman Coulter Inc | Unicel® DXC and SYNCHRON® LX Chemistry Analyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98092 |
| mdprc 061 04 11 000 | SIEMENS | Acuson X300 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84981 |
| mdprc 060 04 11 000 | SIEMENS | Siemens ACUSON Ultrasound systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84555 |
| mdprc 059 04 11 000 | The Anspach Effort, Inc. | Sterile Bone Cutting Bur | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97849 |
| mdprc 058 04 11 000 | Gendex Dental Systems | Orthoralix Panoramic Dental X-Ray Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97680 |
| mdprc 051 04 11 000 | Terumo Cardiovascular Systems Corporation | Sarns Flexible Weighted Sucker | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98691 |
| mdprc 050 04 11 000 | Siemens Medical Solutions | LANTIS Oncology Information System with MEDOne Module | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=80569 |
| mdprc 049 04 11 000 | Siemens Medical Solutions | LANTIS Oncology Information System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84912 |
| mdprc 048 04 11 000 | Medical Positioning Inc | Rapid Response HUT Table | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98168 |
| mdprc 047 04 11 000 | Beckman Coulter Inc | UNICEL DXC SYNCHRON SYSTEMS | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98005 |
| mdprc 046 04 11 000 | Ellex Medical Pty Ltd | Ellex Solo, Ellex Tango, Ellex Super, Alcon and Ellex Ultra ophthalmic lasers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98270 |
| mdprc 045 04 11 000 | DePuy International Limited | DePuy Mitek FMS Irrigation Intermediary Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96020 |
| mdprc 044 04 11 000 | Dental Equipment LLC | DCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spirit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98425 |
| mdprc 035 04 11 000 | Bio-Rad Laboratories Inc | VARIANT II TURBO Hemoglobin, tests Cartridge Sets | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88565 |
| mdprc 034 04 11 000 | Beckman Coulter Inc | Access Free T4 Calibrator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98567 |
| mdprc 029 04 11 000 | Stryker Endoscopy | Inflow/Outflow Cannula | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98484 |
| mdprc 028 04 11 000 | Siemens Medical Solutions | ACUSON S2000 Ultrasound System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=80551 |
| mdprc 027 04 11 000 | Penner Mfg Inc | Penner Patient Transfer/Lift System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98916 |
| mdprc 026 04 11 000 | GE Healthcare | GE CARESCAPE Monitor | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98873 |
| mdprc 025 04 11 000 | Bio-Rad Laboratories Inc | Variant II Turbo | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89009 |
| mdprc 024 04 11 000 | Biomet Inc | CURVTEK eye needle | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98788 |
| mdprc 023 04 11 000 | Teleflex Medical | Rusch Irrigation Tray w/Bulb | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97966 |
| mdprc 022 04 11 000 | Steris Corp | Harmony Monitor Arm Adapter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98365 |
| mdprc 021 04 11 000 | Linvatec Corp | Articulating Arm, Secondary Flat Panel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97963 |
| mdprc 020 04 11 000 | Beaver Visitec International Ltd | BD Beaver XStar Safety Crescent Knife | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98366 |
| mdprc 010 04 11 000 | Siemens Medical Solutions | TEE Transducer, Ultrasound System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84089 |
| mdprc 009 04 11 000 | King Systems Corp. | King LT(S)-D Oropharyngeal Airway | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97483 |
| mdprc 008 04 11 000 | ConMed Linvatec Corporation | Micro Sagittal Blade | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97969 |
| mdprc 007 04 11 000 | Stanley Healthcare Solutions | Stanley Bed-Check | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97928 |
| mdprc 006 04 11 000 | ITC | Hgb Pro Professional Hemoglobin Testing system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97375 |
| mdprc 005 04 11 000 | HemoCue A B | HEMOCUE Analyzers | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96752 |
| mdprc 004 04 11 000 | Cincinnati Sub-Zero Products Inc | Blanketrol Hyper/Hypothermia System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97410 |
| mdprc 003 04 11 000 | Becton Dickinson & Co. (BD) | BD Phoenix" Panel | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98199 |
| mdprc 002 04 11 000 | BD Biosciences | CellQuest Pro SW | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96797 |
| mdprc 121 03 11 000 | Bio-Rad Laboratories Inc | VARIANT Sickle Cell Short Program | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92217 |
| mdprc 115 03 11 000 | Stryker Instruments | Interventional Pain - Percutaneous Discectomy Probe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97708 |
| mdprc 114 03 11 000 | Siemens Medical Solutions | ACUSON Systems, SONOVISTA Systems, SONOLINE Antares Systems, Antares PE Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94615 |
| mdprc 113 03 11 000 | Siemens Medical Solutions | Acuson S2000 Ultrasound System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89306 |
| mdprc 112 03 11 000 | Siemens Medical Solutions | Coherence Dosimetrist | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89038 |
| mdprc 110 03 11 000 | SIEMENS | ACUSON AcuNav ultrasound catheters | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84253 |
| mdprc 109 03 11 000 | Philips Medical Systems | Brilliance 64 ( Computed Tomography X-Ray System) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96631 |
| mdprc 108 03 11 000 | Ossur | Ossur Total Knee | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97954 |
| mdprc 107 03 11 000 | DePuy International Limited | (Attached) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96113 |
| mdprc 106 03 11 000 | Beckman Coulter Inc | Access Thyroglobulin Antibody II | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97800 |
| mdprc 103 03 11 000 | Philips Medical Systems | Allura FD10, FD20, CV20 systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95402 |
| mdprc 102 03 11 000 | DiaSorin Inc | ETI-AB-AUK PLUS kits | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97783 |
| mdprc 101 03 11 000 | Depuy Orthopaedics, Inc | AFFIXUS Lag Screw Drill | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97749 |
| mdprc 100 03 11 000 | ThermoFisher Scientific | Thermo Scientific Microm HM 550 Cold Disinfection Cryostat, Thermo Scientific HM 560 Cold Disinfection Cryostat, | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97577 |
| mdprc 099 03 11 000 | DiaDexus, Inc | PLAC Test ELISA Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94160 |
| mdprc 080 03 11 000 | Stryker Endoscopy | Stryker Stiletto Electrosurgical Probe (E-Probe) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=91342 |
| mdprc 078 03 11 000 | Medtronic Xomed Inc | Thermasplint Kit, Nasal Splint Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98265 |
| mdprc 077 03 11 000 | King Systems Corp. | King Systems LT-D and LTS-D Oropharyngeal Airway | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97875 |
| mdprc 076 03 11 000 | Hill Rom Inc | Sabina Sit-in-Stand lifts | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97285 |
| mdprc 075 03 11 000 | GE Healthcare | GE senographe system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97346 |
| mdprc 074 03 11 000 | Cytyc Prenatal Products/Hologic Inc | Rapid fFN (collection kit) | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87585 |
| mdprc 073 03 11 000 | Bio-Rad Laboratories Inc | PhD System EIA/IFA Software | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97382 |
| mdprc 072 03 11 000 | Abbott Laboratories Inc | CELL-DYN Emerald Hematology Analyzer System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90074 |
| mdprc 071 03 11 000 | Abbott Laboratories Inc | Abbott brand CELL-DYN Emerald Diluent Reagent | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95077 |
| mdprc 070 03 11 000 | Abbott Laboratories Inc | The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88956 |
| mdprc 069 03 11 000 | Abbott Laboratories Inc | Abbott CELL-DYN | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=81733 |
| mdprc 053 03 11 000 | TomoTherapy Incorporated | TomoTherapy Hi-ART radiotherapy System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97745 |
| mdprc 052 03 11 000 | Roche Diagnostics Corp | Factor V Leiden kit, Factor II (prothrombin) kit, MagNA Pure LC 2.0 Instrument | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96480 |
| mdprc 051 03 11 000 | Bio-Rad Laboratories Inc | Autoimmune EIA Anti-dsDNA Test Kit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92481 |
| mdprc 050 03 11 000 | Medtronic Spine LLC Co | Medtronic Bone Cement | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88623 |
| mdprc 049 03 11 000 | Gen Probe Incorporated | AccuProbe | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90838 |
| mdprc 048 03 11 000 | Abbott Point of Care | i-STAT G3+ Cartridge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94168 |
| mdprc 047 03 11 000 | Abbott Laboratories Inc | CELL-DYN 4000 Vent Head Spring Assembly | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88541 |
| mdprc 034 03 11 000 | Terumo Cardiovascular Systems Corporation | Terumo Advanced Perfusion System 1 | FDA |
| mdprc 033 03 11 000 | Siemens Medical Solutions | MOSAIQ Oncology Information System | FDA |
| mdprc 032 03 11 000 | Luxottica Optical Manufacturing | Polycarbonate prescription single vision lenses | FDA |
| mdprc 031 03 11 000 | Hill Rom Inc | TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom. | FDA |
| mdprc 030 03 11 000 | Biomet Inc | ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850 | FDA |
| mdprc 026 03 11 000 | Ethicon Inc | Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only | FDA |
| mdprc 025 03 11 000 | Siemens Medical Solutions | ARTISTE System Digital Linear Accelerator | FDA |
| mdprc 024 03 11 000 | Bio-Rad Laboratories Inc | Bio-Rad PhD System | FDA |
| mdprc 023 03 11 000 | Philips Healthcare | BuckyDiagnost with Optimus Generator | FDA |
| mdprc 022 03 11 000 | Bio-Rad Laboratories Inc | Quantase Neonatal Accessory Kits | FDA |
| mdprc 021 03 11 000 | Medtronic Navigation Inc | Surgical Navigation System | FDA |
| mdprc 020 03 11 000 | Elekta Inc | Desktop Pro | FDA |
| mdprc 019 03 11 000 | Gendex Dental Systems | Wall Mounting Plate | FDA |
| mdprc 018 03 11 000 | Elekta Inc | PrecisePLAN Treatment Planning System | FDA |
| mdprc 017 03 11 000 | Fresenius Medical Care | Hemodialysis Machine | FDA |
| mdprc 016 03 11 000 | Elekta Inc | PrecisePLAN Treatment Planning System | FDA |
| mdprc 015 03 11 000 | Biomet Inc | Cylindrical Bullet Nose Reamer | FDA |
| mdprc 014 03 11 000 | Aesculap Inc | Aesculap MicroSpeed Uni Control Box | FDA |
| mdprc 012 03 11 000 | Roche Diagnostics Corp | COBAS AmpliPrep/COBAS TaqMan | FDA |
| mdprc 011 03 11 000 | Quidel Corporation | QuickVue One-Step hCG Urine test | FDA |
| mdprc 066 02 11 000 | Cook Inc | Central Venous Catheter Tray | FDA |
| mdprc 065 02 11 000 | Siemens Medical Solutions | ARTISTE MV with Artiste Digital Linear Accelerators | FDA |
| mdprc 064 02 11 000 | Integra LifeSciences Corporation | Integra Radionics HRAIM Intubation Head Ring Assembly | FDA |
| mdprc 063 02 11 000 | Hill Rom Inc | Comfort Sling Plus | FDA |
| mdprc 062 02 11 000 | AGFA Corp. | Cardiovascular Review Station | FDA |
| mdprc 060 02 11 000 | SIEMENS | ACUSON S2000 ultrasound system , V5M TEE Transducer | FDA |
| mdprc 059 02 11 000 | Generic Medical Devices | GMD UNIVERSAL URINARY INCONTINENCE SLING | FDA |
| mdprc 058 02 11 000 | DePuy International Limited | S-ROM distal femoral cutting block guide | FDA |
| mdprc 047 02 11 000 | Arrow International Inc | JUGULAR PUNCTURE KIT, Catheterization kit , Anesthesia kit and Arterial line kit , | FDA |
| mdprc 046 02 11 000 | Heart Sync, Inc | Medstorm Adult Radiolucent Electrode | FDA |
| mdprc 045 02 11 000 | Gendex Dental Systems | Panoramic Dental X-Ray System | FDA |
| mdprc 044 02 11 000 | Aspen Surgical Products, Inc. | Corneal Marking Pad | FDA |
| mdprc 043 02 11 000 | Abbott Point of Care | Celite ACT Cartridge | FDA |
| mdprc 040 02 11 000 | Ortho Organizers Inc | ClassOne Orthodontics Buccal SS Tubes | FDA |
| mdprc 039 02 11 000 | GE Healthcare | GE Centricity Laboratory | FDA |
| mdprc 038 02 11 000 | Bio-Rad Laboratories Inc | Bio-Rad Variant II Turbo Link Hemoglobin Testing System | FDA |
| mdprc 037 02 11 000 | Abbott | Blood Glucose Monitoring Test Strips | FDA |
| mdprc 036 02 11 000 | Terumo Cardiovascular Systems Corporation | VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM | FDA |
| mdprc 035 02 11 000 | Elekta Inc | Leksell GammaPlan ( radiation therapy) | FDA |
| mdprc 034 02 11 000 | AMS Innovative Center - San Jose | AMS GreenLight PV Surgical Laser System | FDA |
| mdprc 023 02 11 000 | MAQUET Cardiovascular LLC | HEARTSTRING Aortic Cutter 4.3 mm | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94678 |
| mdprc 022 02 11 000 | International Technidyne Corporation | Hemochron Whole Blood Coagulation Systems | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96055 |
| mdprc 021 02 11 000 | Hill Rom Inc | TotalCare Bed | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97267 |
| mdprc 020 02 11 000 | Abaxis Inc | Piccolo Comprehensive Metabolic Reagent Disc | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95843 |
| mdprc 019 02 11 000 | Siemens Medical Solutions | Linear Medical Accelerator ARTISTE MV system | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84556 |
| mdprc 016 02 11 000 | Stryker Howmedica Osteonics Corp | Orthopaedics device, Omnifit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93724 |
| mdprc 015 02 11 000 | Radiometer America Inc | Blood Analyzer , ABL90 FLEX | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95727 |
| mdprc 014 02 11 000 | Medtronic Navigation Inc | Vertex Max Drill Tube | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96537 |
| mdprc 013 02 11 000 | IMPAC Medical Systems Inc | SEQUENCER for Mosaiq . | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90908 |
| mdprc 012 02 11 000 | Vital Signs Inc A GE Healthcare Co | GreenLight II Laryngoscope Handles | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96283 |
| mdprc 011 02 11 000 | Peak Surgical | Tissue Dissection Device, PEAK brand PlasmaBlade EXT | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84458 |
| mdprc 010 02 11 000 | Arstasis Inc. | Access Kit, Arstasls One Access System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96420 |
| mdprc 007 02 11 000 | Varian Medical Systems | Varian brand C-Series Clinacs and Acuity, Exact Couch Top | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93281 |
| mdprc 006 02 11 000 | Solta Medical, Inc. | Fraxel restore® Dual Laser System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96741 |
| mdprc 005 02 11 000 | Siemens Medical Solutions | Acuson Antares PE , Acuson with Physio Module , ACUSON S2000 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86504 |
| mdprc 004 02 11 000 | Accuray Inc | CyberKnife Treatment Planning System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88658 |
| mdprc 082 01 11 000 | King Systems Corp. | KING LT -D Laryngeal Tube, Oropharyngeal Airway | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88259 |
| mdprc 081 01 11 000 | Boston Scientific Corporation | RF Ablation System Foot Switch, used with the EPT-1000 RF Generator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84916 |
| mdprc 050 01 11 000 | Stryker Instruments. | SmartPump Tourniquet Pump | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94405 |
| mdprc 049 01 11 000 | Mizuho OSI | Operating Room Table, Mizuho ProFx 6850 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94677 |
| mdprc 048 01 11 000 | Cook Endoscopy. | Cholangioscopy Access Balloon | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96679 |
| mdprc 047 01 11 000 | Abbott Point of Care. | i-STAT G3+, CG8+Cartridge | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93504 |
| mdprc 032 01 11 000 | Siemens Medical Solutions. | Acuson Antares Ultrasound System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89055 |
| mdprc 031 01 11 000 | Carl Zeiss Meditec Inc. | Surgical microscope, VISU 200 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=83806 |
| mdprc 029 01 11 000 | Philips Nuclear Medicine. | Precedence SPECT/CT System Upper Patient Pallet. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79567 |
| mdprc 028 01 11 000 | Concentric Medical Inc. | Concentric 7F Balloon Guide Catheter | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=80199 |
| mdprc 027 01 11 000 | Bunnell Inc. | Life Pulse High-Frequency Ventilators. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96004 |
| mdprc 026 01 11 000 | Accuray Inc. | RoboCouch Patient Support System, a subsystem of the Cyberknife Robotic Radiosurgery System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84538 |
| mdprc 020 01 11 000 | Vance Products Incorporated. | Universa Soft Ureteral Stent and positioner | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95928 |
| mdprc 019 01 11 000 | Stryker Endoscopy. | Stryker Digital Capture Pro 2 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88894 |
| mdprc 014 01 11 000 | Boston Scientific Corporation. | Guide Catheter. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89014 |
| mdprc 013 01 11 000 | Terumo Cardiovascular Systems Corporation. | Terumo Advanced Perfusion System 1. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96152 |
| mdprc 009 01 11 000 | AngioScore Inc. | Angioplasty Scoring Balloon Catheters, AngioSculpt Percutaneous Transluminal | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95719 |
| mdprc 002 01 11 000 | Galil Medical Inc. | Urethral Warmer System. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95676 |
| mdprc 001 01 11 000 | AMS Innovative Center - San Jose. | Laser System, GreenLight MoXy Fiber Optic. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94467 |